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Senior Specialist, Clinical Operations – Contracting & Budgeting
Job in
Lawrence, Essex County, Massachusetts, 01842, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Responsibilities
- Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
- Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
- Providing strategic input into study feasibility, start‑up planning, and early budget development
- Ensuring contracts and budgets comply with company policies, regulatory standards, and regional requirements
- Collaborating closely with Clinical Operations, Finance, Legal, and study teams to drive timely execution and approvals
- Identifying financial, operational and regional risks and proactively proposing mitigation strategies
- Tracking contract and budget performance, reporting trends and key metrics
- Driving continuous improvement initiatives to enhance efficiency, consistency, and best practices
- Acting as a subject matter expert on contract templates, budget models, and industry standards
- A Bachelor's degree in Life Sciences, Business, Finance, or a related field, with a Masters degree preferred
- 5 to 7 or more years of experience in clinical research contracting, budget negotiation, or clinical operations finance
- Strong expertise in negotiating clinical trial agreements and site budgets for industry sponsored studies
- Solid knowledge of ICH GCP, FDA, EMA and global clinical research compliance requirements
- Excellent analytical, financial and problem‑solving skills with strong attention to detail
- Clear and confident communication skills with the ability to influence stakeholders at all levels
- Experience with contract management systems and Microsoft Office, with eTMF and CTMS experience preferred
Position Requirements
10+ Years
work experience
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