Site Contracts Analyst - Clinical Trial Site Contracts
About The Position
About This Role: As a Site Contracts Manager, you will be an integral part of the Qualitative Sciences & Development Operations team, focusing on the preparation and negotiation of Clinical Trial Agreements and related contracts. Your role is crucial in ensuring that contract terms align with study needs while safeguarding Biogen’s interests. You will work closely with study and legal teams to meet startup timelines, fostering strong relationships with clinical sites and ancillary facilities. Managing status tracking, you ensure Biogen is always ready for inspection and audit. Additionally, you will support CROs in contract negotiations and serve as an escalation point for language issues. Your insights will drive continuous process improvements, enhancing our institutional knowledge and negotiation strategies. Who You Are: You are a highly organized individual with a knack for negotiation and a strong attention to detail. Your ability to manage time and priorities independently sets you apart, allowing you to handle a high volume of work efficiently. You thrive in cross-functional teams, where your excellent communication skills foster collaboration and drive results. Your proactive approach and problem-solving mindset ensure that you effectively navigate complex contractual negotiations, making you a valuable asset to the team.
Requirements
- Bachelor's Degree in a scientific or business discipline.
- A minimum of 2 years’ experience in the biotechnology/pharmaceutical industry, specifically in site contract negotiation and execution across Phase I-IV clinical trials.
- Thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
- Excellent negotiation, conflict resolution, and communication skills.
- Ability to manage time and priorities independently with minimal oversight.
Nice To Haves
- JD/Paralegal Certification preferred.
- Experience working with cross-functional teams to achieve operational goals.
- Strong analytical skills for identifying contract trends and implementing improvements.
- Familiarity with budget negotiation and financial analysis in clinical trial settings.
Responsibilities
- Negotiate Clinical Trial Agreements with assigned sites to ensure alignment with Biogen’s interests.
- Manage status tracking and reporting, keeping all stakeholders informed and updated.
- Attend study team meetings to collaborate on study progress and contract execution.
- Negotiate Master Clinical Trial Agreements as necessary to support study objectives.
- Support CROs with contract negotiations and serve as an escalation point for unresolved issues.
- Analyze contract trends to identify and implement process improvements.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
