Customer Services Representative page is loaded Customer Services Representative Apply locations Hayes - Office time type Full time posted on Posted 2 Days Ago job requisition id JR- Company: Uniphar Group Division: On - Demand Department: International Sales Role: Customer Services Representative Reporting line: Samantha Michael Primary Location: Hayes - UK Uniphar - Who we are With a workforce of more than 3000 employees spread across Ireland, United Kingdom, Mainland Europe, MENA, and the USA, Uniphar is a trusted global partner to pharma and MedTech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams. Uniphar is organised into three key divisions: Supply Chain Retail & On Demand, Uniphar Med Tech and Uniphar Pharma. Supply Chain & Retail Supply Chain Services provides both pre-wholesale and wholesale distribution of pharmaceutical, healthcare and animal health products to pharmacies and hospital nationwide. The business supports a diverse customer base through the provision of strong service levels coupled with innovative commercial initiatives. In addition, the business provides services and supports that help independent community pharmacy to compete more effectively in an increasingly difficult environment and runs a network of Uniphar-owned pharmacies under the Life, Allcare, McCauleys and Hickeys symbol brands. Pharma - On Demand The On-Demand business is a specialist medical supply business that sources and distributes pharmaceuticals, medical equipment, and consumable supplies to healthcare professionals in over 160 countries worldwide. We have offices in Ireland, UK, Europe, USA and New Zealand. The company's main divisions encompass everything from International Sales through Sales to NGO's and Charities, Clinical Trials Supply, Imported (Unlicensed Medicines), Sexual Health Supplies, and the storage and distribution of medical products and devices for third parties. Click here to find out more: About Us - Who we are Uniphar Culture at Uniphar Uniphar is a combination of many businesses each with its own identity, culture, values, and ways of working. Our overarching culture narrative is inclusive of each of these stores. Uniphar lives and breathes four key pillars which unpin and support our culture. We have a people first approach - we do the right thing. We support entrepreneurial spirit where adaptability, commitment & resilience is embodied in our way of working. We have a Common Purpose that connects our diversified businesses and people. Finally, Trust is at the heart of how we operate. Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture. Sustainability Sustainability is at the core of what we do and is deeply embedded in our business strategy. We want to contribute positively to the people and the world around us. Running our business in a sustainable way ensures that Uniphar will continue to prosper in the long-term. We are focused on ensuring that each of the five pillars of our sustainability strategy are a fundamental part of our decision-making process. The Role This is a customer service role, focused on ensuring consistent exemplary customer experience is provided to our International customers. Working with the sales team, the Customer Service Representative will through urgency, quality and reliability deliver value to our customers in need of access to medicines on a global scale enabling Durbin, Part of the Uniphar Group to become the number 1 supplier of choice for International Sales/Exports via our UK Head office. Key Outcomes Supporting the sales team to provide a best-in-class customer experience, while aligning to business strategies and objectives with a focus on maximising value within Key Markets Ensure customer orders are managed appropriately within specified SLA. Establish a working relationship with the Procurement and sales teams. Monitor backorders and track shipments where required so we can ensure high customer service expectations are met. Collaborating with Internally divisions to ensure all relevant paperwork and documentation is in place to comply with GDP practices whilst supporting and driving all regulations in force relating to the supply of medicines and medical devices. Supporting product set up's on ASC, following guidelines on product set up's, and managing master data. Support on setting up new customers including annual validation, following through with QA and Finance. Any other duties that may arise relating to the support of the account managers to drive growth and profitability. Administration & Finance Support the sales team in achieving performance against agreed budgetary targets. Ensure all customer details are up to date across the company systems. Qualification, Experience & Skills Required An understanding of the domestic supply and UK importation of unlicensed medication. Prolific IT skills (MS Office, Excel, PowerPoint etc). 3 years minimum experience in a customer facing/service role. Competencies Positive can-do attitude. Ability to work on own initiative. Communicates in a professional manner and effectively manages customer liaison. Works well within a team, flexible and willing to share the workload both ways. Demonstrates ambition and initiative in their work. Open to change in a fast-moving industry and to new learning. Be results orientated to achievement of team budget. Be supportive of colleagues in a team environment. Should adhere to the service values of Durbin On Demand. Excellent communications skills including verbal, written and presentational. Ability to learn new business processes and operate training provided on new IT applications. This role will be based in our office in Hayes where a flexible hybrid working model is also available. It's important to achieve the right balance between face-to-face interactions with virtual working over the long term. Moreover, there will be flexibility required to interact with colleagues (i.e., it's not a '9 to 5' type of job). In return for your flexibility, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it. If you believe that you meet most of the criteria above, we encourage you to apply. We are an equal opportunities employer and will ensure any reasonable accommodations are implemented About Us Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the Top Workplace in the area.
Jul 17, 2025
Full time
Customer Services Representative page is loaded Customer Services Representative Apply locations Hayes - Office time type Full time posted on Posted 2 Days Ago job requisition id JR- Company: Uniphar Group Division: On - Demand Department: International Sales Role: Customer Services Representative Reporting line: Samantha Michael Primary Location: Hayes - UK Uniphar - Who we are With a workforce of more than 3000 employees spread across Ireland, United Kingdom, Mainland Europe, MENA, and the USA, Uniphar is a trusted global partner to pharma and MedTech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams. Uniphar is organised into three key divisions: Supply Chain Retail & On Demand, Uniphar Med Tech and Uniphar Pharma. Supply Chain & Retail Supply Chain Services provides both pre-wholesale and wholesale distribution of pharmaceutical, healthcare and animal health products to pharmacies and hospital nationwide. The business supports a diverse customer base through the provision of strong service levels coupled with innovative commercial initiatives. In addition, the business provides services and supports that help independent community pharmacy to compete more effectively in an increasingly difficult environment and runs a network of Uniphar-owned pharmacies under the Life, Allcare, McCauleys and Hickeys symbol brands. Pharma - On Demand The On-Demand business is a specialist medical supply business that sources and distributes pharmaceuticals, medical equipment, and consumable supplies to healthcare professionals in over 160 countries worldwide. We have offices in Ireland, UK, Europe, USA and New Zealand. The company's main divisions encompass everything from International Sales through Sales to NGO's and Charities, Clinical Trials Supply, Imported (Unlicensed Medicines), Sexual Health Supplies, and the storage and distribution of medical products and devices for third parties. Click here to find out more: About Us - Who we are Uniphar Culture at Uniphar Uniphar is a combination of many businesses each with its own identity, culture, values, and ways of working. Our overarching culture narrative is inclusive of each of these stores. Uniphar lives and breathes four key pillars which unpin and support our culture. We have a people first approach - we do the right thing. We support entrepreneurial spirit where adaptability, commitment & resilience is embodied in our way of working. We have a Common Purpose that connects our diversified businesses and people. Finally, Trust is at the heart of how we operate. Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture. Sustainability Sustainability is at the core of what we do and is deeply embedded in our business strategy. We want to contribute positively to the people and the world around us. Running our business in a sustainable way ensures that Uniphar will continue to prosper in the long-term. We are focused on ensuring that each of the five pillars of our sustainability strategy are a fundamental part of our decision-making process. The Role This is a customer service role, focused on ensuring consistent exemplary customer experience is provided to our International customers. Working with the sales team, the Customer Service Representative will through urgency, quality and reliability deliver value to our customers in need of access to medicines on a global scale enabling Durbin, Part of the Uniphar Group to become the number 1 supplier of choice for International Sales/Exports via our UK Head office. Key Outcomes Supporting the sales team to provide a best-in-class customer experience, while aligning to business strategies and objectives with a focus on maximising value within Key Markets Ensure customer orders are managed appropriately within specified SLA. Establish a working relationship with the Procurement and sales teams. Monitor backorders and track shipments where required so we can ensure high customer service expectations are met. Collaborating with Internally divisions to ensure all relevant paperwork and documentation is in place to comply with GDP practices whilst supporting and driving all regulations in force relating to the supply of medicines and medical devices. Supporting product set up's on ASC, following guidelines on product set up's, and managing master data. Support on setting up new customers including annual validation, following through with QA and Finance. Any other duties that may arise relating to the support of the account managers to drive growth and profitability. Administration & Finance Support the sales team in achieving performance against agreed budgetary targets. Ensure all customer details are up to date across the company systems. Qualification, Experience & Skills Required An understanding of the domestic supply and UK importation of unlicensed medication. Prolific IT skills (MS Office, Excel, PowerPoint etc). 3 years minimum experience in a customer facing/service role. Competencies Positive can-do attitude. Ability to work on own initiative. Communicates in a professional manner and effectively manages customer liaison. Works well within a team, flexible and willing to share the workload both ways. Demonstrates ambition and initiative in their work. Open to change in a fast-moving industry and to new learning. Be results orientated to achievement of team budget. Be supportive of colleagues in a team environment. Should adhere to the service values of Durbin On Demand. Excellent communications skills including verbal, written and presentational. Ability to learn new business processes and operate training provided on new IT applications. This role will be based in our office in Hayes where a flexible hybrid working model is also available. It's important to achieve the right balance between face-to-face interactions with virtual working over the long term. Moreover, there will be flexibility required to interact with colleagues (i.e., it's not a '9 to 5' type of job). In return for your flexibility, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it. If you believe that you meet most of the criteria above, we encourage you to apply. We are an equal opportunities employer and will ensure any reasonable accommodations are implemented About Us Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the Top Workplace in the area.
EXPERIENCED INTERNAL ACCOUNT MANAGER / CUSTOMER SERVICE ADVISOR REQUIRED FROM A NON-RETAIL, CALL CENTRE TEAM TYPE BACKGROUND TO DEAL WITH A RANGE OF CLIENTS IN THE WASTE & RECYCLING SECTOR ROLE: Internal Account Manager / Customer Service Advisor SALARY: 28-35,000 plus Bonus and Benefits LOCATION: Between Wakefield & Castleford, this role is 100% office based, no hybrid working available. Previous roles may have been: Internal Account Manager, Telesales Executive, Compliance Administrator, Customer Service Advisor, Account Manager, Internal Account Coordinator, Waste Management Graduate, Account Executive, Service Delivery Advisor, Internal Sales Executive, Field Sales Executive You may have worked in (not essential): Waste Management, Recycling, Clinical Waste, Metal Recycling, Organics Recycling, Waste Electricals, Aggregates Recycling, Skip Hire, Hazardous Waste, WEEE, Plant Hire, Washroom Services, Workwear, Laundry Services, Hygiene Services, Pest Control, Commercial Cleaning, Industrial Cleaning, Industrial Services, Catering Services, Building Supplies, POS Solutions CORE DUTIES: Internal Account Manager / Customer Service Advisor Delivery of a high level of customer service, dealing with phone and email-based enquiries Arrange collections of waste goods for recycling Conduct customer waste audits Look for additional sales opportunities with existing clients EXPERIENCE: Internal Account Manager / Customer Service Advisor You will have a UK Driving Licence You will communicate clearly via the telephone and have a good standard of written English You will be conversant with MS Office and be quick to familiarize yourself with new software systems Any Environmental compliance experience a great benefit Previous roles may have been: Internal Account Manager, Telesales Executive, Compliance Administrator, Customer Service Advisor, Account Manager, Internal Account Coordinator, Waste Management Graduate, Account Executive, Service Delivery Advisor, Internal Sales Executive, Field Sales Executive
Mar 09, 2025
Full time
EXPERIENCED INTERNAL ACCOUNT MANAGER / CUSTOMER SERVICE ADVISOR REQUIRED FROM A NON-RETAIL, CALL CENTRE TEAM TYPE BACKGROUND TO DEAL WITH A RANGE OF CLIENTS IN THE WASTE & RECYCLING SECTOR ROLE: Internal Account Manager / Customer Service Advisor SALARY: 28-35,000 plus Bonus and Benefits LOCATION: Between Wakefield & Castleford, this role is 100% office based, no hybrid working available. Previous roles may have been: Internal Account Manager, Telesales Executive, Compliance Administrator, Customer Service Advisor, Account Manager, Internal Account Coordinator, Waste Management Graduate, Account Executive, Service Delivery Advisor, Internal Sales Executive, Field Sales Executive You may have worked in (not essential): Waste Management, Recycling, Clinical Waste, Metal Recycling, Organics Recycling, Waste Electricals, Aggregates Recycling, Skip Hire, Hazardous Waste, WEEE, Plant Hire, Washroom Services, Workwear, Laundry Services, Hygiene Services, Pest Control, Commercial Cleaning, Industrial Cleaning, Industrial Services, Catering Services, Building Supplies, POS Solutions CORE DUTIES: Internal Account Manager / Customer Service Advisor Delivery of a high level of customer service, dealing with phone and email-based enquiries Arrange collections of waste goods for recycling Conduct customer waste audits Look for additional sales opportunities with existing clients EXPERIENCE: Internal Account Manager / Customer Service Advisor You will have a UK Driving Licence You will communicate clearly via the telephone and have a good standard of written English You will be conversant with MS Office and be quick to familiarize yourself with new software systems Any Environmental compliance experience a great benefit Previous roles may have been: Internal Account Manager, Telesales Executive, Compliance Administrator, Customer Service Advisor, Account Manager, Internal Account Coordinator, Waste Management Graduate, Account Executive, Service Delivery Advisor, Internal Sales Executive, Field Sales Executive
Salary: EUR Monthly Hours:36.00 - 40.00 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK Senior Scientist Enzyme and Oligonucleotide Development (EOD) UK We are seeking a motivated Oligonucleotide chemist to join the Enzyme and Oligonucleotide Development (EOD) department at GSK's flagship R&D site at Stevenage in Hertfordshire. As a Senior Scientist in EOD UK you will use your process chemistry knowledge and expertise to optimise routes for manufacture of oligonucleotide active pharmaceutical ingredients (APIs) and contribute to the development and deployment of state-of-the-art processes and technologies enabling the delivery of our medicines. Potentially, you will lead significant parts of chemistry development programs, directing the work of other scientists globally in a matrix team. As projects advance through development there may be opportunities to lead pilot plant supplies across scales, culminating in the transfer of projects to commercial manufacturing facilities around the globe. The role is highly technical and dynamic as you will be working in several multi-disciplinary project teams. You will thrive in this environment if you are able to effectively manage multiple priorities, communicate your recommendations clearly, and enjoy working in teams. Based at our R&D hub at Stevenage, the concentration of a large number of scientists inspires a culture of inclusion, equity and diversity with a common goal of innovation and collaboration. The location also benefits from excellent facilities on site and in the surrounding area as well as fast train access to central London and Cambridge. This role is on-site laboratory based but there may be some flexibility for remote working when work permits with manager approval. In this role you will: Design and implement chemical routes and processes to oligonucleotide APIs suitable for scale up, with a focus on process understanding and the acquisition of the right data to support global regulatory filings Optimise chemical manufacturing processes complying with safety, quality, speed, cost, sustainability, reproducibility, and regulatory requirements in all aspects of work Have oversight of API manufacture on g to multi-ton scale to support clinical, regulatory, and commercial launch activities; potentially run internal facilities to support early tox API supply Work to cGMP standards as appropriate Participate in technology transfer activities to transfer new manufacturing processes to our commercial manufacturing partners as appropriate Generate comprehensive conclusion reports, author or contribute to regulatory submissions, patents, scientific papers, and other internal and external documentation relevant to the role Collaborate closely with scientists including analytical colleagues to contribute to accelerated development of new medicines Potentially lead projects within a CMC environment Why you? Basic Qualifications/Essentials: We are looking for professionals with these required skills to achieve our goals: PhD or equivalent academic or industrial laboratory-based experience in Oligonucleotide Chemistry Proven track record of laboratory-scale chemistry execution and creative problem-solving skills, with the ability to identify and resolve potential issues effectively in a multi-functional team Preferred Qualifications & Skills: We are looking for professionals with these preferred skills to achieve our goals: Extensive knowledge of oligonucleotide chemistry including potential routes of impurity formation Practical experience of laboratory scale oligonucleotide synthesis, purification and isolation using Cytiva equipment and Unicorn software Familiarity with techniques for development and understanding of scalable chemical processes e.g., kinetics, statistical design of experiments. Experience working with exploratory data analysis techniques in a programming environment, ideally involving analysis of oligonucleotide synthesis/purification data. Familiarity with control strategy requirements, e.g., analytical specifications, impurity purging and fate mapping, genotoxic impurity risk assessment Ability to effectively communicate in a multi-disciplinary working environment, ensuring every department is informed throughout the scientific division Closing Date for Applications: Sunday 23rd March 2025. To apply, please visit our website via the button below. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements. The information that you have provided in your cover letter and CV will be used to assess your application. GSK R&D At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Find out more: Our approach to R&D Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or . The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive. As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses / Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license . click apply for full job details
Mar 06, 2025
Full time
Salary: EUR Monthly Hours:36.00 - 40.00 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK Senior Scientist Enzyme and Oligonucleotide Development (EOD) UK We are seeking a motivated Oligonucleotide chemist to join the Enzyme and Oligonucleotide Development (EOD) department at GSK's flagship R&D site at Stevenage in Hertfordshire. As a Senior Scientist in EOD UK you will use your process chemistry knowledge and expertise to optimise routes for manufacture of oligonucleotide active pharmaceutical ingredients (APIs) and contribute to the development and deployment of state-of-the-art processes and technologies enabling the delivery of our medicines. Potentially, you will lead significant parts of chemistry development programs, directing the work of other scientists globally in a matrix team. As projects advance through development there may be opportunities to lead pilot plant supplies across scales, culminating in the transfer of projects to commercial manufacturing facilities around the globe. The role is highly technical and dynamic as you will be working in several multi-disciplinary project teams. You will thrive in this environment if you are able to effectively manage multiple priorities, communicate your recommendations clearly, and enjoy working in teams. Based at our R&D hub at Stevenage, the concentration of a large number of scientists inspires a culture of inclusion, equity and diversity with a common goal of innovation and collaboration. The location also benefits from excellent facilities on site and in the surrounding area as well as fast train access to central London and Cambridge. This role is on-site laboratory based but there may be some flexibility for remote working when work permits with manager approval. In this role you will: Design and implement chemical routes and processes to oligonucleotide APIs suitable for scale up, with a focus on process understanding and the acquisition of the right data to support global regulatory filings Optimise chemical manufacturing processes complying with safety, quality, speed, cost, sustainability, reproducibility, and regulatory requirements in all aspects of work Have oversight of API manufacture on g to multi-ton scale to support clinical, regulatory, and commercial launch activities; potentially run internal facilities to support early tox API supply Work to cGMP standards as appropriate Participate in technology transfer activities to transfer new manufacturing processes to our commercial manufacturing partners as appropriate Generate comprehensive conclusion reports, author or contribute to regulatory submissions, patents, scientific papers, and other internal and external documentation relevant to the role Collaborate closely with scientists including analytical colleagues to contribute to accelerated development of new medicines Potentially lead projects within a CMC environment Why you? Basic Qualifications/Essentials: We are looking for professionals with these required skills to achieve our goals: PhD or equivalent academic or industrial laboratory-based experience in Oligonucleotide Chemistry Proven track record of laboratory-scale chemistry execution and creative problem-solving skills, with the ability to identify and resolve potential issues effectively in a multi-functional team Preferred Qualifications & Skills: We are looking for professionals with these preferred skills to achieve our goals: Extensive knowledge of oligonucleotide chemistry including potential routes of impurity formation Practical experience of laboratory scale oligonucleotide synthesis, purification and isolation using Cytiva equipment and Unicorn software Familiarity with techniques for development and understanding of scalable chemical processes e.g., kinetics, statistical design of experiments. Experience working with exploratory data analysis techniques in a programming environment, ideally involving analysis of oligonucleotide synthesis/purification data. Familiarity with control strategy requirements, e.g., analytical specifications, impurity purging and fate mapping, genotoxic impurity risk assessment Ability to effectively communicate in a multi-disciplinary working environment, ensuring every department is informed throughout the scientific division Closing Date for Applications: Sunday 23rd March 2025. To apply, please visit our website via the button below. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements. The information that you have provided in your cover letter and CV will be used to assess your application. GSK R&D At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Find out more: Our approach to R&D Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or . The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive. As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses / Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license . click apply for full job details
Site Name: UK - London - Brentford Posted Date: Sep 9 2022 Join the GSK Industrial Placement UK Programme as an Associate Clinical Development Scientist:Help us get ahead of disease together. Education required: Undergraduate degree from an accredited university, preferably in Life Sciences. Other requirements: You will have completed a minimum of 2 years of your undergraduate degree but will not have graduated at the start of your placement. You must be enrolled at a UK university for the duration of your placement. Language requirement: Written and spoken fluency in English Expected Start date: 4th September 2023 Duration: 1 year (approximately) Location: GSK House - Brentford, Stevenage, and Addenbrookes Hospital GSK CUC. Application deadline: Friday 14th October 2022. We will close this vacancy when we have enough applications, so we recommend that you apply as soon as you can so your application can be considered. Proposed Assessment / Interview Dates: The majority of R&D interviews will take place in the first two weeks of November Salary: A salary of £22,500, plus a bonus (GSK House - Brentford) A salary of £21,000, plus a bonus (Stevenage and Addenbrookes Hospital) Please read below about the 2 different positions we are recruiting for across our Associate Clinical Development Scientist Industrial Placements. Please note, these are distinct placements and so when you apply you will be able to select preferences of where you would like to be placed if successful. We will accommodate your preference where possible. Role 1 - Associate Clinical Development Scientist (Study Management) Location: GSK House or Stevenage Within this role your day-to-day responsibilities will be involved in the testing of new medicines in humans. The role holder will provide project management, operational and technical support to the Study Delivery Leads (SDL) and study teams. This will include: Support study set up and project management activities Support and assist coordination of the required ethics application of designated studies. Focus on study set- up and operational project management and close out activities. Working with your SDL your responsibilities may include but are not limited to: Operational delivery of clinical studies (including, for example: feasibility assessments, overseeing subcontractor's performance, recruitment tracking) Preparation of high-quality scientific materials relating to clinical trials (including, for example: contributing to clinical study protocols, procedures manuals, information and consent forms) Attendance at and contribution to clinical study team meetings. Review of data and writing of associated reports. Assist with planning and tracking of study timelines and budgets. Co-ordinate key study activities such as study documentation filing, study supplies and investigator meetings. Participating in scientific discussions relating to the design of clinical studies You may also be asked to assist with other departmental activities that are not study related. Role 2 - Associate Clinical Development Scientist (GSK Clinical Unit Cambridge, CUC) Location: GSK Clinical Unit Cambridge, Addenbrookes Hospital This role is based in GSK's Phase 1 Clinical unit situated within Addenbrookes Hospital. The role holder will provide project management, operational and technical support to the Clinical Development Managers (CDM) and study teams. This will include: Support study set up and project management activities Support and assist coordination of the required ethics application of designated studies. Focus on study set- up and operational project management and close out activities. Working with the CDM team you will learn: To ensure compliance with regulatory and ethical standards. Maintain accurate and complete study records consistent with company policy and legal and regulatory requirements. Site file maintenance to ensure accurate maintenance of study records for monitoring and inspection-readiness of the site investigator file. Support study scheduling, management of bed occupancy spreadsheet and planning clinical timelines Develop and maintain study budgets. Identify and implement process improvements. Team leadership, management and communication, including meeting management with the unit and GSK study teams. Support the day to day management and running of clinical trials, supporting the clinical teams. Who are we looking for? A keen passion for clinical development - tell us your hobbies or interests that are connected to clinical development, R&D, the commercial world and the biopharma industry Appetite to build strong relationships with key stakeholders Adaptability to change and working under pressure Excellent communication skills that help you influence Strong problem-solving skills driven by curiosity You enjoy learning in action and confidence You are a keen learner The ability to prioritise What do we offer you? A salary of £22,500, plus a bonus (GSK House - Brentford) or salary of £21,000, plus a bonus (Stevenage and Addenbrookes Hospital) Access to GSK resources, including employee assistance programmes, private healthcare and well-being programs and pension plan membership On-the-job experience and informal training and development, delivered through a mixture of coaching, mentoring, and training programs A GSK placement which gives you the opportunity to take on a real role with genuine impact You will join a GSK Industrial Placement community of over 250 students across the UK and business areas Access to LinkedIn groups to enable the new Industrial Placement community to network and connect before start date For R&D placements you will also be enrolled in several GSK internal courses as part of company policy such as data integrity, use of internal electronic lab book, laboratory safety rules. Within R&D you will have the opportunity to attend seminars by GSK scientists, which run throughout the year and comprise of a wide range of areas within drug discovery. Please read above about the 2 different positions we are recruiting for across our Associate Clinical Development Scientist Industrial Placements. Please note, these are distinct placements and so when you apply you will be able to select preferences of where you would like to be placed if successful. We will accommodate your preference where possible. Are you looking to gain valuable real world work experience and help positively impact the lives of others GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. A GSK internship offers you the opportunity to kickstart your career - to take on a real role with genuine impact. You'll take on challenging tasks within live projects or assignments. You'll also get to learn from others in your team and other parts of GSK whilst developing your skills and gaining valuable experience for wherever the future takes you. Inspired to help us get ahead together? Apply for an Associate Clinical Development Scientist Industrial Placement role at GSK today! Our approach to R&D focuses on science related to the prevention and treatment of disease with vaccines, specialty and general medicines. We focus on science of the immune system, human genetics and advanced technologies to impact health at scale. Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. Find out more: Our approach to R&D . Let's do this! This opportunity has the following recruitment stages you must successfully pass to be offered a placement year with GSK for 2023: 1. Eligibility Form 2. World of GSK Online Assessment 3. Application Form 4. Virtual Assessment Centre or Virtual Interview You'll find hints, tips and guidance on our recruitment process on our website - Apply now for our Early Talent programmes GSK We will close this vacancy when we have enough applications, so we recommend that you apply as soon as you can so your application can be considered. You can learn more about GSK and our careers here . Apply now! We're 100% open to ALL people We're 100% open to all talent - whatever your gender, marital status, religion, age, colour, race, sexual orientation, nationality, learning difference or disability. We want to recruit the right people for GSK from the widest possible backgrounds, so we can better serve the diversity of our patients and also because it's the right thing to do. You can learn more about Inclusion and diversity at GSK here . Need help with your application? Please email us at or call is on and let us know how we can help you. ..... click apply for full job details
Sep 24, 2022
Full time
Site Name: UK - London - Brentford Posted Date: Sep 9 2022 Join the GSK Industrial Placement UK Programme as an Associate Clinical Development Scientist:Help us get ahead of disease together. Education required: Undergraduate degree from an accredited university, preferably in Life Sciences. Other requirements: You will have completed a minimum of 2 years of your undergraduate degree but will not have graduated at the start of your placement. You must be enrolled at a UK university for the duration of your placement. Language requirement: Written and spoken fluency in English Expected Start date: 4th September 2023 Duration: 1 year (approximately) Location: GSK House - Brentford, Stevenage, and Addenbrookes Hospital GSK CUC. Application deadline: Friday 14th October 2022. We will close this vacancy when we have enough applications, so we recommend that you apply as soon as you can so your application can be considered. Proposed Assessment / Interview Dates: The majority of R&D interviews will take place in the first two weeks of November Salary: A salary of £22,500, plus a bonus (GSK House - Brentford) A salary of £21,000, plus a bonus (Stevenage and Addenbrookes Hospital) Please read below about the 2 different positions we are recruiting for across our Associate Clinical Development Scientist Industrial Placements. Please note, these are distinct placements and so when you apply you will be able to select preferences of where you would like to be placed if successful. We will accommodate your preference where possible. Role 1 - Associate Clinical Development Scientist (Study Management) Location: GSK House or Stevenage Within this role your day-to-day responsibilities will be involved in the testing of new medicines in humans. The role holder will provide project management, operational and technical support to the Study Delivery Leads (SDL) and study teams. This will include: Support study set up and project management activities Support and assist coordination of the required ethics application of designated studies. Focus on study set- up and operational project management and close out activities. Working with your SDL your responsibilities may include but are not limited to: Operational delivery of clinical studies (including, for example: feasibility assessments, overseeing subcontractor's performance, recruitment tracking) Preparation of high-quality scientific materials relating to clinical trials (including, for example: contributing to clinical study protocols, procedures manuals, information and consent forms) Attendance at and contribution to clinical study team meetings. Review of data and writing of associated reports. Assist with planning and tracking of study timelines and budgets. Co-ordinate key study activities such as study documentation filing, study supplies and investigator meetings. Participating in scientific discussions relating to the design of clinical studies You may also be asked to assist with other departmental activities that are not study related. Role 2 - Associate Clinical Development Scientist (GSK Clinical Unit Cambridge, CUC) Location: GSK Clinical Unit Cambridge, Addenbrookes Hospital This role is based in GSK's Phase 1 Clinical unit situated within Addenbrookes Hospital. The role holder will provide project management, operational and technical support to the Clinical Development Managers (CDM) and study teams. This will include: Support study set up and project management activities Support and assist coordination of the required ethics application of designated studies. Focus on study set- up and operational project management and close out activities. Working with the CDM team you will learn: To ensure compliance with regulatory and ethical standards. Maintain accurate and complete study records consistent with company policy and legal and regulatory requirements. Site file maintenance to ensure accurate maintenance of study records for monitoring and inspection-readiness of the site investigator file. Support study scheduling, management of bed occupancy spreadsheet and planning clinical timelines Develop and maintain study budgets. Identify and implement process improvements. Team leadership, management and communication, including meeting management with the unit and GSK study teams. Support the day to day management and running of clinical trials, supporting the clinical teams. Who are we looking for? A keen passion for clinical development - tell us your hobbies or interests that are connected to clinical development, R&D, the commercial world and the biopharma industry Appetite to build strong relationships with key stakeholders Adaptability to change and working under pressure Excellent communication skills that help you influence Strong problem-solving skills driven by curiosity You enjoy learning in action and confidence You are a keen learner The ability to prioritise What do we offer you? A salary of £22,500, plus a bonus (GSK House - Brentford) or salary of £21,000, plus a bonus (Stevenage and Addenbrookes Hospital) Access to GSK resources, including employee assistance programmes, private healthcare and well-being programs and pension plan membership On-the-job experience and informal training and development, delivered through a mixture of coaching, mentoring, and training programs A GSK placement which gives you the opportunity to take on a real role with genuine impact You will join a GSK Industrial Placement community of over 250 students across the UK and business areas Access to LinkedIn groups to enable the new Industrial Placement community to network and connect before start date For R&D placements you will also be enrolled in several GSK internal courses as part of company policy such as data integrity, use of internal electronic lab book, laboratory safety rules. Within R&D you will have the opportunity to attend seminars by GSK scientists, which run throughout the year and comprise of a wide range of areas within drug discovery. Please read above about the 2 different positions we are recruiting for across our Associate Clinical Development Scientist Industrial Placements. Please note, these are distinct placements and so when you apply you will be able to select preferences of where you would like to be placed if successful. We will accommodate your preference where possible. Are you looking to gain valuable real world work experience and help positively impact the lives of others GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. A GSK internship offers you the opportunity to kickstart your career - to take on a real role with genuine impact. You'll take on challenging tasks within live projects or assignments. You'll also get to learn from others in your team and other parts of GSK whilst developing your skills and gaining valuable experience for wherever the future takes you. Inspired to help us get ahead together? Apply for an Associate Clinical Development Scientist Industrial Placement role at GSK today! Our approach to R&D focuses on science related to the prevention and treatment of disease with vaccines, specialty and general medicines. We focus on science of the immune system, human genetics and advanced technologies to impact health at scale. Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. Find out more: Our approach to R&D . Let's do this! This opportunity has the following recruitment stages you must successfully pass to be offered a placement year with GSK for 2023: 1. Eligibility Form 2. World of GSK Online Assessment 3. Application Form 4. Virtual Assessment Centre or Virtual Interview You'll find hints, tips and guidance on our recruitment process on our website - Apply now for our Early Talent programmes GSK We will close this vacancy when we have enough applications, so we recommend that you apply as soon as you can so your application can be considered. You can learn more about GSK and our careers here . Apply now! We're 100% open to ALL people We're 100% open to all talent - whatever your gender, marital status, religion, age, colour, race, sexual orientation, nationality, learning difference or disability. We want to recruit the right people for GSK from the widest possible backgrounds, so we can better serve the diversity of our patients and also because it's the right thing to do. You can learn more about Inclusion and diversity at GSK here . Need help with your application? Please email us at or call is on and let us know how we can help you. ..... click apply for full job details
Job title: Clinical Team Manager Location: UK based, fully remote Sponsor dedicated ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities Working fully embedded within one of our global pharmaceutical clients, with the support of ICON right behind you, you ll be at the heart of our client s innovation. As a Clinical Team Manager you will be dedicated to one of our global pharmaceutical clients who aim to use science-based innovation to deliver better patient outcomes. They aim to lead in growing areas of healthcare. The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities. May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input Assess appropriateness of study for local environment Conducts country/site feasibility. Leads selection of sites within country; accountable for site performance. Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning. Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management. Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning. Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department. With oversight; Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials. Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally. Responsible for submitting or assisting with (in accordance with local regulations and our client's standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals. Arranges accurate translations of key study documentation into local language as required. Provides support / develops and negotiates Clinical Trial Agreements (depending on our client's local practices) with the investigational sites, ensuring legal input where required. Ensures necessary supplies are available at sites and manages local supply inventory. Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed. Build close working relationships with key partners including local medical staff. Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training. Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports. Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy. Escalates resourcing issues to ensure that in-country study activities are appropriately resourced. Ensures robust communication with sites, e.g. timely communication of protocol amendments. Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status. Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting). Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards. Reviews, ensures completeness and maintains accuracy of Sponsor Study Records. Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement. Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills. Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions. Qualifications What do you need to have? Education: Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse Required skills 8 years of relevant experience Right to work in the UK Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners. Solid understanding of country local regulations, ICH-GCP guidelines and company written standards. Flexible and resilient with ability to evolve in changing and challenging environment. Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Sep 23, 2022
Full time
Job title: Clinical Team Manager Location: UK based, fully remote Sponsor dedicated ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities Working fully embedded within one of our global pharmaceutical clients, with the support of ICON right behind you, you ll be at the heart of our client s innovation. As a Clinical Team Manager you will be dedicated to one of our global pharmaceutical clients who aim to use science-based innovation to deliver better patient outcomes. They aim to lead in growing areas of healthcare. The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities. May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input Assess appropriateness of study for local environment Conducts country/site feasibility. Leads selection of sites within country; accountable for site performance. Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning. Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management. Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning. Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department. With oversight; Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials. Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally. Responsible for submitting or assisting with (in accordance with local regulations and our client's standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals. Arranges accurate translations of key study documentation into local language as required. Provides support / develops and negotiates Clinical Trial Agreements (depending on our client's local practices) with the investigational sites, ensuring legal input where required. Ensures necessary supplies are available at sites and manages local supply inventory. Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed. Build close working relationships with key partners including local medical staff. Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training. Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports. Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy. Escalates resourcing issues to ensure that in-country study activities are appropriately resourced. Ensures robust communication with sites, e.g. timely communication of protocol amendments. Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status. Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting). Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards. Reviews, ensures completeness and maintains accuracy of Sponsor Study Records. Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement. Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills. Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions. Qualifications What do you need to have? Education: Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse Required skills 8 years of relevant experience Right to work in the UK Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners. Solid understanding of country local regulations, ICH-GCP guidelines and company written standards. Flexible and resilient with ability to evolve in changing and challenging environment. Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Job Title: Pre-Sales Manager (Clinical Supplies) Location: Home-based, Europe preferred Salary: Competitive Position: Full Time, Permanent Travel Required: Yes, 50% expected across Europe & US About the role: This is an exciting position for candidates with a passion for business technology and process improvement. This role will support the Global Sales Team in growing our business within the Clinical Supply (Clinical Trial) sector. PRISYM ID's enterprise Label Lifecycle Management (LLM) solutions already enjoy a proven track record with many of the world's top Clinical Supply organisations, affording great reference ability. Job Duties: The role will involve working closely with the PRISYM ID Sales team and clients' subject matter experts from multiple departments including: operations, research & development, packaging & labelling, supply chain, procurement, manufacturing, regulatory and quality. Candidates will ideally have proven experience in a Pre-Sales role or have held a position in a consultative or operational capacity within the clinical supply chain. Responsibilities will include Assist the Sales team by technically qualifying new opportunities and by providing technical leadership throughout the sales process including leading customer discussions regarding business process improvement, solution architecture, systems validation (GxP) and implementation/migration strategies. Attend customer/prospect meetings to assist Sales identify demonstrable business value. Work with prospect and client stakeholders to evaluate and understand their business requirements. These are typically presented as RFI, RFP or URS (User Requirements Specification) documents which will be formally responded to. Build and deliver compelling customer-facing sales demonstrations and presentation of our solution offerings to provide customer education and assist with requirements analysis. Technical support to the Sales team to generate profitable business. Assist the sales team in the creation of sales quotations, estimates, proposal documents and Statement of Work (SoW) documents. Set agendas for and run customer-facing requirements workshops to identify current processes, required inputs and outputs, process improvements and mapping of content to the solution. Facilitating the handover between the Sales and Professional Service delivery teams for completed contracts. Work closely with the VP Global Product to stay current with product releases and to ensure that the Sales team have access to the latest tools to demonstrate to customers. Use of internal systems to provide weekly and monthly reporting for planning and forecasting. Pursue personal development skills and knowledge necessary for the effective performance of the role becoming a labelling solution subject matter expert within the Clinical Trials sector. About you: Required Communication Skills Professional written and verbal skills both internally and externally - must be confident talking to Business Users and Technologists alike Ability to gather customer needs accurately and relate these to the solution (product and services) offered Ability to build strong customer relationships Excellent communicator able to present complex technical concepts to a non-technical audience Required Technical Skills Ability to manage and co-ordinate complex RFI/RFP processes Experience of proposal writing and RFI/RFP responses Excellent knowledge of Microsoft Office Suite of products including Visio In depth knowledge of Cloud/SaaS and on-premise system architectures Understanding of web-based technologies and applications High level understanding of relational databases (SQL Server, Oracle) The ability to create and deliver technical presentations and demonstrations of an enterprise solution to a wide audience Ability to relate software features to business process benefits and vice versa Preferred Skills & Experience Experience of managing complex extended duration projects Previous experience of packaging and labeling within regulated industries Previous experience working for a company delivering global solutions Formal product or project management experience Knowledge of the Life Sciences (preferably Clinical Trials) market is a bonus as is understanding of computer system validation and FDA 21 CFR Part 11 The role is suitable for those looking to make a real-world and measurable difference to our organization - our collaboration with the world's leading Pharmaceutical and Clinical Supplies organisations will lead to ongoing improvement of patient health and patient safety. Please click the APPLY button to send your CV for this role. Candidates with previous experience and job titles of; Sales Team Leader, Sales Operations Manager, Sales Operations Analyst, Business Development Manager, Sales Support Manager will be considered for this role.
Dec 07, 2021
Full time
Job Title: Pre-Sales Manager (Clinical Supplies) Location: Home-based, Europe preferred Salary: Competitive Position: Full Time, Permanent Travel Required: Yes, 50% expected across Europe & US About the role: This is an exciting position for candidates with a passion for business technology and process improvement. This role will support the Global Sales Team in growing our business within the Clinical Supply (Clinical Trial) sector. PRISYM ID's enterprise Label Lifecycle Management (LLM) solutions already enjoy a proven track record with many of the world's top Clinical Supply organisations, affording great reference ability. Job Duties: The role will involve working closely with the PRISYM ID Sales team and clients' subject matter experts from multiple departments including: operations, research & development, packaging & labelling, supply chain, procurement, manufacturing, regulatory and quality. Candidates will ideally have proven experience in a Pre-Sales role or have held a position in a consultative or operational capacity within the clinical supply chain. Responsibilities will include Assist the Sales team by technically qualifying new opportunities and by providing technical leadership throughout the sales process including leading customer discussions regarding business process improvement, solution architecture, systems validation (GxP) and implementation/migration strategies. Attend customer/prospect meetings to assist Sales identify demonstrable business value. Work with prospect and client stakeholders to evaluate and understand their business requirements. These are typically presented as RFI, RFP or URS (User Requirements Specification) documents which will be formally responded to. Build and deliver compelling customer-facing sales demonstrations and presentation of our solution offerings to provide customer education and assist with requirements analysis. Technical support to the Sales team to generate profitable business. Assist the sales team in the creation of sales quotations, estimates, proposal documents and Statement of Work (SoW) documents. Set agendas for and run customer-facing requirements workshops to identify current processes, required inputs and outputs, process improvements and mapping of content to the solution. Facilitating the handover between the Sales and Professional Service delivery teams for completed contracts. Work closely with the VP Global Product to stay current with product releases and to ensure that the Sales team have access to the latest tools to demonstrate to customers. Use of internal systems to provide weekly and monthly reporting for planning and forecasting. Pursue personal development skills and knowledge necessary for the effective performance of the role becoming a labelling solution subject matter expert within the Clinical Trials sector. About you: Required Communication Skills Professional written and verbal skills both internally and externally - must be confident talking to Business Users and Technologists alike Ability to gather customer needs accurately and relate these to the solution (product and services) offered Ability to build strong customer relationships Excellent communicator able to present complex technical concepts to a non-technical audience Required Technical Skills Ability to manage and co-ordinate complex RFI/RFP processes Experience of proposal writing and RFI/RFP responses Excellent knowledge of Microsoft Office Suite of products including Visio In depth knowledge of Cloud/SaaS and on-premise system architectures Understanding of web-based technologies and applications High level understanding of relational databases (SQL Server, Oracle) The ability to create and deliver technical presentations and demonstrations of an enterprise solution to a wide audience Ability to relate software features to business process benefits and vice versa Preferred Skills & Experience Experience of managing complex extended duration projects Previous experience of packaging and labeling within regulated industries Previous experience working for a company delivering global solutions Formal product or project management experience Knowledge of the Life Sciences (preferably Clinical Trials) market is a bonus as is understanding of computer system validation and FDA 21 CFR Part 11 The role is suitable for those looking to make a real-world and measurable difference to our organization - our collaboration with the world's leading Pharmaceutical and Clinical Supplies organisations will lead to ongoing improvement of patient health and patient safety. Please click the APPLY button to send your CV for this role. Candidates with previous experience and job titles of; Sales Team Leader, Sales Operations Manager, Sales Operations Analyst, Business Development Manager, Sales Support Manager will be considered for this role.
Job Advert Posting ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. As a Senior Project Manager, Laboratory you will ensure client satisfaction by acting as the clients main contact from set up to day to management of studies. *The Role:* * Act as the sponsor's main contact person in all matters regarding our central laboratory services, following up to and responding to clinical study specific inquiries from a range of internal & external stakeholders. * Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate). * Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan * Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure. * Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems. * Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist * Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation * Set the timelines for and monitor the progress of shipment requests for storage samples and verify data. * Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings. * Serve as a leader, mentor and consultant to more junior team members in resolving issues or questions as they arise. * Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management *To be successful in the role, you will ideally have:* * In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization * Prior relevant experience successfully performing a Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture. * Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defences * Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training. *Benefits of Working in ICON:* Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Dec 06, 2021
Full time
Job Advert Posting ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. As a Senior Project Manager, Laboratory you will ensure client satisfaction by acting as the clients main contact from set up to day to management of studies. *The Role:* * Act as the sponsor's main contact person in all matters regarding our central laboratory services, following up to and responding to clinical study specific inquiries from a range of internal & external stakeholders. * Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate). * Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan * Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure. * Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems. * Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist * Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation * Set the timelines for and monitor the progress of shipment requests for storage samples and verify data. * Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings. * Serve as a leader, mentor and consultant to more junior team members in resolving issues or questions as they arise. * Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management *To be successful in the role, you will ideally have:* * In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization * Prior relevant experience successfully performing a Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture. * Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defences * Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training. *Benefits of Working in ICON:* Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
CK Group are recruiting for a Senior CRA to join a specialist Clinical Research Organisation on a contract basis. The Senior Clinical Research Associate (CRA) is part of the Clinical Operations team and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements. The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Location: This position will be home based, but candidates must be able and willing to to travel up to 60% of the time. Salary: Competitive days rates are on offer for candidates with the right level of experience and knowledge. Key responsibilities: - Monitor on-site and remotely clinical trials in accordance with client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines - Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data - Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA - Initiates corrective action to resolve issues as directed by supervisor - Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager - Participate in contract handling and negotiation directed by Lead CRA/Project Manager - Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites. - In cooperation with study team, responsible for SMF maintenance - Order, ship, and reconcile clinical investigative supplies for study sites, if applicable - Order, ship and coordination of study supplies at site - May prepare and submit status reports as directed by Lead CRA/PM - Review and support site staff to maintain SMF - Review Informed Consent documents for essential elements and protocol specifics - Update CTMS system with site and study information - May audit data in tables and text of clinical summaries - May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness - Prepare check requisitions for sponsor Project Manager approval, when applicable Your Background: - Bachelor's Degree, preferably in life science or nursing; or equivalent - Minimum 1-3 years of relevant clinical experience - Ophthalmology experience is required - Able to work in a fast paced environment with changing priorities - Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas - Possess the understanding of Good Clinical Practice regulations, ICH guidelines - Ability to work independently as well as in a team matrix organization - Excellent written and verbal communication skills. - Excellent organizational skills - Ability and willingness to travel up to 60-70% Apply: For more information or to apply for this Senior CRA position, please contact Steve Lord on or email , quoting job ref 52261. It is essential that applicants hold entitlement to work in the UK. CLINGEN
Dec 05, 2021
Full time
CK Group are recruiting for a Senior CRA to join a specialist Clinical Research Organisation on a contract basis. The Senior Clinical Research Associate (CRA) is part of the Clinical Operations team and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements. The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Location: This position will be home based, but candidates must be able and willing to to travel up to 60% of the time. Salary: Competitive days rates are on offer for candidates with the right level of experience and knowledge. Key responsibilities: - Monitor on-site and remotely clinical trials in accordance with client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines - Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data - Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA - Initiates corrective action to resolve issues as directed by supervisor - Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager - Participate in contract handling and negotiation directed by Lead CRA/Project Manager - Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites. - In cooperation with study team, responsible for SMF maintenance - Order, ship, and reconcile clinical investigative supplies for study sites, if applicable - Order, ship and coordination of study supplies at site - May prepare and submit status reports as directed by Lead CRA/PM - Review and support site staff to maintain SMF - Review Informed Consent documents for essential elements and protocol specifics - Update CTMS system with site and study information - May audit data in tables and text of clinical summaries - May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness - Prepare check requisitions for sponsor Project Manager approval, when applicable Your Background: - Bachelor's Degree, preferably in life science or nursing; or equivalent - Minimum 1-3 years of relevant clinical experience - Ophthalmology experience is required - Able to work in a fast paced environment with changing priorities - Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas - Possess the understanding of Good Clinical Practice regulations, ICH guidelines - Ability to work independently as well as in a team matrix organization - Excellent written and verbal communication skills. - Excellent organizational skills - Ability and willingness to travel up to 60-70% Apply: For more information or to apply for this Senior CRA position, please contact Steve Lord on or email , quoting job ref 52261. It is essential that applicants hold entitlement to work in the UK. CLINGEN
Labcorp Drug Development is currently recruiting for an experienced 'Career CTA'to join our client's growing team inWest London. We need applicants who enjoy complex administrative duties; someone who is hugely organized and passionate about taking ownership of their role. Consequently we looking for a 'career' clinical administrator who does not wish to progress to a CRA or Study Manager. This client-dedicated role is to be 100% office based in West London and ideally you will have at least 2 - 5 years experience of supporting Clinical Trials in the UK. * Overview: * The Senior Clinical Trial Administrator, CTA, performs study-related tasks as required by the Department, including: communicate with Project Team and members of the project team regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide system's support, track information related to the status of study activities and assist with general administrative functions as required. * Essential Job Duties: * 1) Documenting and tracking study activities using relevant forms and tools, as well as relevant Project Management System. 2) Preparation of study site specific materials in accordance with relevant SOPs 3) Complete minute taking and documentation for sponsor/external or internal teleconferences as requested 4) Setting up and maintaining tracking systems for e.g. study supplies and investigator payments 5) Create and main contact list of study team members, study sites, and external suppliers/contract organizations 6) Support Investigator Meetings. 7) Train and mentor less experienced Clinical Trial Administrators 8) Set up and maintain clinical investigator files and documentation 9) Assist with coordinating study level vendors as requested 10) Organize/prepare for client meetings/teleconferences 11) Liaise with all other departments to ensure the smooth running of the study as needed 12) Provide clerical support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.) 13) Maintain paper trial master file documentation and tracking/archiving as applicable 14) Might be requested to work in a client facing environment 15) Perform other administrative duties as assigned by management * Other Information: * This role is a full time & permanent position to be employed through Labcorp. For more information please contact Andy Smith on or mail Education/Qualifications: Good GCSEs Experience: * Basic understanding of biology and biological processes * Good organizational and time management skills * Good communication skills, oral and written * Exhibit general computer literacy * Fluent in English, both written and verbal
Dec 04, 2021
Full time
Labcorp Drug Development is currently recruiting for an experienced 'Career CTA'to join our client's growing team inWest London. We need applicants who enjoy complex administrative duties; someone who is hugely organized and passionate about taking ownership of their role. Consequently we looking for a 'career' clinical administrator who does not wish to progress to a CRA or Study Manager. This client-dedicated role is to be 100% office based in West London and ideally you will have at least 2 - 5 years experience of supporting Clinical Trials in the UK. * Overview: * The Senior Clinical Trial Administrator, CTA, performs study-related tasks as required by the Department, including: communicate with Project Team and members of the project team regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide system's support, track information related to the status of study activities and assist with general administrative functions as required. * Essential Job Duties: * 1) Documenting and tracking study activities using relevant forms and tools, as well as relevant Project Management System. 2) Preparation of study site specific materials in accordance with relevant SOPs 3) Complete minute taking and documentation for sponsor/external or internal teleconferences as requested 4) Setting up and maintaining tracking systems for e.g. study supplies and investigator payments 5) Create and main contact list of study team members, study sites, and external suppliers/contract organizations 6) Support Investigator Meetings. 7) Train and mentor less experienced Clinical Trial Administrators 8) Set up and maintain clinical investigator files and documentation 9) Assist with coordinating study level vendors as requested 10) Organize/prepare for client meetings/teleconferences 11) Liaise with all other departments to ensure the smooth running of the study as needed 12) Provide clerical support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.) 13) Maintain paper trial master file documentation and tracking/archiving as applicable 14) Might be requested to work in a client facing environment 15) Perform other administrative duties as assigned by management * Other Information: * This role is a full time & permanent position to be employed through Labcorp. For more information please contact Andy Smith on or mail Education/Qualifications: Good GCSEs Experience: * Basic understanding of biology and biological processes * Good organizational and time management skills * Good communication skills, oral and written * Exhibit general computer literacy * Fluent in English, both written and verbal
