Manager, Site Contracts Management
About The Position
As the Manager, Site Contracts Management, you will play a pivotal role in the execution of Clinical Trial Agreements between our company and study sites, ensuring seamless conduct of global clinical trials. You will provide strategic global study-level support, championing a best-in-class approach to site contract management for Phase I-IV clinical trials and scientific research collaborations. Your responsibilities will span from the study planning stage through the lifecycle of the clinical trial, maintaining oversight of CROs to ensure compliant and timely execution of site contracts and payments across multiple regions. Additionally, you will support site contract language guidance, address escalations from CROs, and collaborate with our R&D Legal team to resolve complex negotiations. Acting as a regional subject matter expert, you will contribute to country-level contract strategy and support in-house site contract development and negotiation as needed. Your keen eye for trends will drive the refinement of existing guidance, tools, and templates, contributing to process and guideline development and maintenance.
Requirements
- Bachelor’s degree
- 6+ years’ experience in the biotechnology/pharmaceutical industry within the site contracting outsourcing space.
- Fully proficient in project management and site contract and budget negotiation and execution across Phase I-IV clinical trials.
- Thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
- Excellent negotiation skills, conflict resolution, decision-making skills, and presentation skills.
- Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.
- Bachelor’s Degree required; MBA/MPA/MPH/JD (or equivalent) preferred but not required.
Nice To Haves
- Experience in related areas of clinical operations, such as site start-up management or regulatory affairs.
- Familiarity with global clinical trial agreements and scientific research collaborations.
Responsibilities
- Provide consistent site contract global strategy, oversight, and support at the study level for all operating models on assigned studies.
- Serve as an escalation point for language issues from CROs and liaise with R&D Legal to resolve complex negotiations.
- Contribute to department and cross-functional process development and improvements.
- Develop and maintain oversight of CROs to ensure compliant and timely execution of site contracts and payments.
- Provide strategic input on country-level contracts strategy as a regional SME.
- Support in-house site contract development and negotiation as necessary.
- Monitor trends and contribute to the refinement of existing guidance, tools, and templates.
- Facilitate communication between study sites and internal teams to ensure alignment and compliance.
- Ensure adherence to GCP, relevant ICH standards, and FDA/EMA guidelines.
- Conduct presentations and provide training on site contracts best practices.
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
Manager
