Title - Clinical Risk Surveillance Lead Location - UK, Ireland or Spain (remote) Sponsor dedicated As a Clinical Risk Surveillance Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within a growing, global program, you will be responsible for driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. What you will be doing: • Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evalua-tion of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined • Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities • Partners with the RBQM system configuration team to ensure risk indicators, quality tol-erance limits and other analytics/visualizations are programmed and functioning per op-erational requirements in the RBQM system • Conduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerg-ing risks and/or issues • Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies • Supports and participates in internal and external audits and inspection • Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach. You are: Bachelor's Degree in a health-related, life science area, or equivalent combination of education, training, and work experience Minimum of 6 years of experience in the pharmaceutical or CRO industry Minimum of 2 years of experience in Risk Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions Knowledge of RBQM IT systems or other data analytic systems Demonstrated ability to analyze data, identify patterns and make recommendations for improvement Demonstrated ability to effectively lead cross functional team meetings Experience forming cross-functional collaborations; strong interpersonal skills What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Jul 05, 2025
Full time
Title - Clinical Risk Surveillance Lead Location - UK, Ireland or Spain (remote) Sponsor dedicated As a Clinical Risk Surveillance Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within a growing, global program, you will be responsible for driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. What you will be doing: • Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evalua-tion of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined • Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities • Partners with the RBQM system configuration team to ensure risk indicators, quality tol-erance limits and other analytics/visualizations are programmed and functioning per op-erational requirements in the RBQM system • Conduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerg-ing risks and/or issues • Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies • Supports and participates in internal and external audits and inspection • Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach. You are: Bachelor's Degree in a health-related, life science area, or equivalent combination of education, training, and work experience Minimum of 6 years of experience in the pharmaceutical or CRO industry Minimum of 2 years of experience in Risk Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions Knowledge of RBQM IT systems or other data analytic systems Demonstrated ability to analyze data, identify patterns and make recommendations for improvement Demonstrated ability to effectively lead cross functional team meetings Experience forming cross-functional collaborations; strong interpersonal skills What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Job title - CRA (Oncology experience required) Location - Must be based in the UK Sponsor dedicated As a CRA, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within a growing program that specializes in the Oncology space, you will be responsible for assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies. What you will be doing: Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines. Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements. Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial. Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members. Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines. Ensures subjects' rights, safety and well-being are protected. Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events. Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion. Assists and supports data validation and data cleaning procedures to ensure timelines are met. Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations. Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File). Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation. You must have the following: Position requires BA/BS, preferably in the Life Sciences, or RN. Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock. Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials. Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements. Good knowledge of concepts of clinical research and drug development. Strong working knowledge of EDC, IVRS and CTMS systems. Proficiency in the use of Microsoft Office. Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information. Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills. Works with high quality and compliance mindset. Possess a valid driver's license. Must be willing to travel and spend 8-10 days/month on site. Proficient in speaking and writing English and the country language when applicable. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements. A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Feb 15, 2025
Full time
Job title - CRA (Oncology experience required) Location - Must be based in the UK Sponsor dedicated As a CRA, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within a growing program that specializes in the Oncology space, you will be responsible for assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies. What you will be doing: Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines. Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements. Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial. Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members. Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines. Ensures subjects' rights, safety and well-being are protected. Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events. Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion. Assists and supports data validation and data cleaning procedures to ensure timelines are met. Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations. Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File). Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation. You must have the following: Position requires BA/BS, preferably in the Life Sciences, or RN. Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock. Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials. Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements. Good knowledge of concepts of clinical research and drug development. Strong working knowledge of EDC, IVRS and CTMS systems. Proficiency in the use of Microsoft Office. Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information. Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills. Works with high quality and compliance mindset. Possess a valid driver's license. Must be willing to travel and spend 8-10 days/month on site. Proficient in speaking and writing English and the country language when applicable. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements. A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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. *Position overview:* As a Manager / Senior Manager of Regulatory Strategy you will be responsible for the successful execution of regulatory affairs activities within the Regulatory Strategy and Agency Liaison group within ICON. You will have the opportunity to work on a variety of different projects in this client-facing role and perform different development, MAA and lifecycle management activities. your responsibilities will include: * To successfully execute on the regulatory strategy for your assigned projects, managing the agency liaison activities for various products and submissions. * To compile agency submissions for regulatory pathways including but not limited to scientific advice, pediatric investigation plans, orphan drug designations, marketing authorizations, product variations and renewals of international medicinal products. * To provide expert regulatory advice to a range of clients. * To successfully interface and negotiate with international Health Authorities. * To collaborate with other subject matter experts internally at PRA, including Medical Writing, Regulatory Operations, Labelling and CMC. * To manage and guide our clients in their development and post market activities. * To apply your regulatory strategy knowledge to enhance probability of regulatory success or enhancing regulatory compliance. Working in this close-knit team is varied and will evolve as the department grows. As such, you can expect to see your knowledge and career expand in line with this evolution. *Requirements:* * A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional). * A proven track record of success in managing projects and executing on regulatory strategies. * Extensive experience with EU and ideally international markets * Hands-on experience with the submission marketing authorization applications, scientific advice procedures and lifecycle maintenance (renewals, extensions etc) * A collaborative and team-focused approach to work. *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.
Dec 06, 2021
Full time
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. *Position overview:* As a Manager / Senior Manager of Regulatory Strategy you will be responsible for the successful execution of regulatory affairs activities within the Regulatory Strategy and Agency Liaison group within ICON. You will have the opportunity to work on a variety of different projects in this client-facing role and perform different development, MAA and lifecycle management activities. your responsibilities will include: * To successfully execute on the regulatory strategy for your assigned projects, managing the agency liaison activities for various products and submissions. * To compile agency submissions for regulatory pathways including but not limited to scientific advice, pediatric investigation plans, orphan drug designations, marketing authorizations, product variations and renewals of international medicinal products. * To provide expert regulatory advice to a range of clients. * To successfully interface and negotiate with international Health Authorities. * To collaborate with other subject matter experts internally at PRA, including Medical Writing, Regulatory Operations, Labelling and CMC. * To manage and guide our clients in their development and post market activities. * To apply your regulatory strategy knowledge to enhance probability of regulatory success or enhancing regulatory compliance. Working in this close-knit team is varied and will evolve as the department grows. As such, you can expect to see your knowledge and career expand in line with this evolution. *Requirements:* * A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional). * A proven track record of success in managing projects and executing on regulatory strategies. * Extensive experience with EU and ideally international markets * Hands-on experience with the submission marketing authorization applications, scientific advice procedures and lifecycle maintenance (renewals, extensions etc) * A collaborative and team-focused approach to work. *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.
Proposal Analyst Location: Reading/Swansea with some home-based flexibility 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 You will work as part of a Global team working with a wide range of departments across all ICON locations and be instrumental in all stages of the proposal process from initial request though to final version for contract. Driving the development of complex budgets in response to client RFPs Co-ordination and analysis of information gathered from Senior Management Assembling project assumptions working closely with colleagues in other departments, including operations, legal, finance and business development Compiling high quality proposal documents by collecting pertinent study specifications from business leaders Analysing data to ensure essential bid information is accurate and complete You are: Process-driven, a strong communicator, a problem solver and an analytical thinker. A life sciences or finance graduate or relevant career experience can be considered Able to work effectively within a deadline driven environment and are self-motivated with a high degree of efficiency and accuracy Experienced within a pharma or CRO environment would be an advantageous but is not essential Experience working with Microsoft Office including Word and Excel 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.
Dec 05, 2021
Full time
Proposal Analyst Location: Reading/Swansea with some home-based flexibility 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 You will work as part of a Global team working with a wide range of departments across all ICON locations and be instrumental in all stages of the proposal process from initial request though to final version for contract. Driving the development of complex budgets in response to client RFPs Co-ordination and analysis of information gathered from Senior Management Assembling project assumptions working closely with colleagues in other departments, including operations, legal, finance and business development Compiling high quality proposal documents by collecting pertinent study specifications from business leaders Analysing data to ensure essential bid information is accurate and complete You are: Process-driven, a strong communicator, a problem solver and an analytical thinker. A life sciences or finance graduate or relevant career experience can be considered Able to work effectively within a deadline driven environment and are self-motivated with a high degree of efficiency and accuracy Experienced within a pharma or CRO environment would be an advantageous but is not essential Experience working with Microsoft Office including Word and Excel 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.