Site Contracts Specialist/Lead (Sponsor Dedicated) - UK, Hybrid home/office based in Uxbridge, Londo
- Syneos Health
- Jul 09, 2022
Full time
Engineering
Job Description
Site Contracts Specialist / Lead - Sponsor Dedicated
Based in the UK - Hybrid Working (Home-based and office-based in Uxbridge, London) Come discover what out 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number. They're our family, friends and neighbors. Why Syneos Health?
means we're committed to our Total Self Culture - where everyone can authentically be themselves. Our Total Self Culture is what unites us globally, and we know every person's unique contributions make a difference.
We believe our success is a direct results of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures and perspectives - we're able to create a place where everyone feels like they belong.
The Role: With supervision, conduct activities associated with the development and negotiation of site contracts, including company sponsored and investigator sponsored clinical site contracts, non-clinical contracts, confidentiality disclosure agreements, and cooperative research agreements. Job Responsibilities:
Negotiate site study agreements and amendments with limited supervision
Participate as part of the Global Study Teams (Master Clinical Study Agreements, Clinical Study Agreements and ancillary site agreements) with the appointed CRO or affiliate, or directly with the site as appropriate with limited supervision
Escalate to the appropriate colleague when a significant risk to the business is identified
Collaboration with Grant Manager, to ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
Inform key stakeholders on cycle time intelligence and engage early on in the feasibility process when requested
Attend study team meetings
Track and measure project and team timelines and progress of site contracting through collection of cycle time metrics
Use metrics with CRO's and affiliates to identify, manage milestones and risks and appropriate escalation on site contracting
Identify potential risks and manage issue resolution with management oversight
Ensures status reports are provided to appropriate parties both internally and externally on a regular basis
Manage escalations as appropriate and highlight to senior management for direction
Evaluate changes requested within contracts and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review
Comply with audit requests and support to any inspection actions as requested
Actively participate to cross functional regional or global projects
Participate and support moderately complex department specific initiatives and projects
Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs
Contribute to strategy and new processes, identify new best practices, and contribute to continuous improvement
Requires limited supervision
Interact with internal and external customers
Capitalize on strengths of relationships/networks to effectively work with cross functional teams
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
What we're looking for:
BS degree in life sciences, a health related field, or equivalent combination of education and experience.
Significant experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.
Thorough knowledge of applicable regulations, GCP, drug development and clinical project management procedures.
Working knowledge of clinical site contract negotiations and contract terms and conditions
Basic knowledge of financial terms
Competent computer skills
Ability to work as part of a team as well as on an individual basis
Strong organizational skills with the ability to multi-task
Problem solving skills with a commitment to delivering quality work in a deadline-driven environment
Fluency in English languages (written, spoken)
Right to work and live in the UK
Ability to work partially office based in Uxbridge (sponsor based) 2-3 days per week
Get to know Syneos Health:
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Based in the UK - Hybrid Working (Home-based and office-based in Uxbridge, London) Come discover what out 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number. They're our family, friends and neighbors. Why Syneos Health?
means we're committed to our Total Self Culture - where everyone can authentically be themselves. Our Total Self Culture is what unites us globally, and we know every person's unique contributions make a difference.
We believe our success is a direct results of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures and perspectives - we're able to create a place where everyone feels like they belong.
The Role: With supervision, conduct activities associated with the development and negotiation of site contracts, including company sponsored and investigator sponsored clinical site contracts, non-clinical contracts, confidentiality disclosure agreements, and cooperative research agreements. Job Responsibilities:
Negotiate site study agreements and amendments with limited supervision
Participate as part of the Global Study Teams (Master Clinical Study Agreements, Clinical Study Agreements and ancillary site agreements) with the appointed CRO or affiliate, or directly with the site as appropriate with limited supervision
Escalate to the appropriate colleague when a significant risk to the business is identified
Collaboration with Grant Manager, to ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
Inform key stakeholders on cycle time intelligence and engage early on in the feasibility process when requested
Attend study team meetings
Track and measure project and team timelines and progress of site contracting through collection of cycle time metrics
Use metrics with CRO's and affiliates to identify, manage milestones and risks and appropriate escalation on site contracting
Identify potential risks and manage issue resolution with management oversight
Ensures status reports are provided to appropriate parties both internally and externally on a regular basis
Manage escalations as appropriate and highlight to senior management for direction
Evaluate changes requested within contracts and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review
Comply with audit requests and support to any inspection actions as requested
Actively participate to cross functional regional or global projects
Participate and support moderately complex department specific initiatives and projects
Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs
Contribute to strategy and new processes, identify new best practices, and contribute to continuous improvement
Requires limited supervision
Interact with internal and external customers
Capitalize on strengths of relationships/networks to effectively work with cross functional teams
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
What we're looking for:
BS degree in life sciences, a health related field, or equivalent combination of education and experience.
Significant experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.
Thorough knowledge of applicable regulations, GCP, drug development and clinical project management procedures.
Working knowledge of clinical site contract negotiations and contract terms and conditions
Basic knowledge of financial terms
Competent computer skills
Ability to work as part of a team as well as on an individual basis
Strong organizational skills with the ability to multi-task
Problem solving skills with a commitment to delivering quality work in a deadline-driven environment
Fluency in English languages (written, spoken)
Right to work and live in the UK
Ability to work partially office based in Uxbridge (sponsor based) 2-3 days per week
Get to know Syneos Health:
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
About Syneos Health