Position Summary
The Clinical Contract Analyst responsible for preparing, negotiating, and managing clinical trial agreements and related financial and legal documentation with investigational sites, vendors, and other stakeholders. The CCS ensures that contracts are executed in compliance with company policies, ICH-GCP, and all applicable local regulations, supporting efficient clinical trial start-up and maintenance.
Key Responsibilities
Contract Preparation and Negotiation
- Draft, review, negotiate, and finalize clinical trial agreements (CTAs), confidentiality agreements (CDAs), and other site-related legal documents.
- Collaborate with internal stakeholders (Clinical Operations, Finance, Legal, and Procurement) to ensure contract terms align with company standards and project requirements.
- Review and validate study budgets, ensuring consistency with protocol requirements and financial guidelines.
- Facilitate budget discussions with investigator sites and assist in resolving contract-related issues.
Coordination and Tracking
- Track contract progress in internal systems (e.g., CTMS, contract management platforms) and maintain accurate contract status reports.
- Coordinate with Clinical Research Associates (CRAs) and Project Managers to align contract timelines with site activation goals.
- Ensure contracts are fully executed and filed according to internal SOPs and GCP requirements.
- Support ongoing contract amendments and renewals during the trial lifecycle.
Compliance and Quality
- Ensure all contracts comply with applicable laws, company policies, and ethical standards.
- Work closely with Legal and Compliance teams to assess contract risks and propose mitigation strategies.
- Maintain awareness of local and global contracting regulations (e.g., data privacy, anti-bribery, transparency).
- Participate in internal audits and inspections when required.
Stakeholder Communication
- Serve as the main point of contact for contract-related queries from sites, vendors, and internal project teams.
- Build and maintain strong working relationships with investigators, site staff, and internal departments.
- Provide regular status updates to study teams and management regarding contract progress and challenges.