Site Contract Specialist

Job Description: Clinical Study Support Specialist

Under the guidance of the Manager, Site Contracts and Budgets, this position is responsible for driving the tactical delivery of assigned studies or programs for the Global Clinical Study Support Department. The role involves participating on a project team to ensure timely contract and budget negotiations, adhering to financial, contractual, and pharmaceutical R&D industry standards and regulations.

Duties and Responsibilities

1. Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents.
2. Negotiate contractual documents using established plans and escalate as necessary.
3. Track the progress of negotiations and prepare status reports.
4. Facilitate the execution of contractual documents between investigators, sites, and clients.
5. Mentor new or junior staff, providing training and addressing questions/issues.
6. Collaborate with study teams to maintain contract management systems.
7. Serve as the primary contact and escalation point during negotiations.
8. Assist in preparing performance metrics.
9. Notify management of out-of-scope requests, timeline changes, or resource issues.
10. Perform other duties as assigned.

Requirements

• B.A./B.S., preferably in business, science, healthcare, nursing, or an equivalent degree.
• At least five (5) years of experience in a client service role within biotech, pharma, CRO, or healthcare supporting clinical research.
• Experience with Study Start-Up processes.
• Experience with electronic document management systems or similar portals is desirable.