FSP Sr Contract Specialist
Core
Manages the preparation, negotiation, and finalization of Investigator Contracts with study sites, ensuring quality, objectivity, and risk analysis in clinical trial contract delivery.
Role type
Senior Site Contract Specialist
Builds
Investigator Contracts and related agreements for clinical study sites
Domain
Life Sciences / Clinical Research / Contract Law
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contract law principles, Investigator grant budget negotiation, Pharmaceutical product development process knowledge, CRO involvement understanding, Risk analysis, Contractual process compliance, Automated systems usage
Preferred skills
Mentoring junior staff, Country process improvement initiatives, Training material review, Global process compliance, Quality reviews
Technologies
Automated systems, Computerized applications, PPD SOP, WPDs
Responsibilities
Draft, review, negotiate, and finalize agreements with study sites; Identify and assess legal, financial, and operational risks; Coordinate with internal departments to align site startup activities with contractual timelines; Provide recommendations and alternative resolutions for contract negotiations; Complete tracking and reporting; Participate in country process improvement initiatives; Liaise with Global Site Contracts for compliance.
Seniority
Senior, hands-on IC