Site Contract Specialist

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About the Company

Oncology-focused Global Pharmaceutical company

Position Overview

Under the guidance of the Manager, Site Contracts and Budgets, this position is responsible for driving the tactical delivery of assigned studies or programs within the Global Clinical Study Support Department. The role involves participating in project teams 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 negotiation and escalation plans.
3. Track the progress and status of negotiations and prepare status reports as required.
4. Facilitate the execution of contractual documents between investigators, sites, and clients.
5. Mentor new or junior staff, providing training and addressing project questions or issues.
6. Collaborate with study teams to set up and maintain contract management systems that facilitate document creation, distribution, negotiation, and execution.
7. Serve as the primary contact and escalation point for investigator sites, negotiation networks, and study team members during contract negotiations.
8. Assist in preparing performance metrics, such as median cycle times.
9. Notify management of out-of-scope requests, timeline changes, or resource constraints.
10. Perform other duties as assigned.

Requirements

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