Clinical Trial Contract Specialist
Core
Managing the full lifecycle of clinical trial contracts, including drafting, negotiating, and finalizing agreements to support study start-up and trial management.
Role type
Specialist-level contract specialist (clinical trials)
Builds
Clinical trial contracts and legal documents for study start-up
Domain
Clinical research / Contract law
Required skills
Contract drafting, contract negotiation, risk assessment, regulatory compliance, cross-functional coordination
Preferred skills
Prior contract negotiation experience, Law or Life-Sciences background
Technologies
Contract management systems, legal document templates
Responsibilities
Drafting, reviewing, negotiating, and finalizing agreements, termination letters or other legal documents required for a clinical study; Negotiate within client approved contract and budget templates and negotiation parameters; Identify and assess legal, financial, and operational risks and escalate to appropriate Contract Lead or Contract Manager; Provide recommendations and alternative resolutions throughout negotiations using established escalation channels; Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual process and mutually agreed up timelines; Keep up to date with applicable local regulations impacting clinical trial contracts.