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

Senior Specialist, Clinical Operations – Contracting & Budgeting

Key skills