Contract Specialist
Core
Managing the full lifecycle of clinical study contracts, including drafting, negotiating, and finalizing agreements to support study start-up.
Role type
Contract Specialist (Clinical Trials)
Builds
Clinical trial contracts and legal documents for biotechnology, pharmaceutical, and medical device clients.
Domain
Clinical Research / Life Sciences
Required skills
Contract negotiation, legal document drafting, risk assessment, regulatory compliance, cross-functional coordination
Preferred skills
Law or Sciences degree background, prior contract negotiation experience
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 assesses 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.