FSP Associate Contract Specialist/Contract Specialist
Core
Prepare, negotiate, and finalize contracts with clinical study sites and principal investigators to support pharmaceutical clinical trials.
Role type
Associate/Contract Specialist (Clinical Trial Contracts)
Builds
Contractual agreements and related documentation for clinical studies
Domain
Pharmaceutical industry / Clinical Research
Deliverable
client delivery
Required skills
Contract law principles, investigator grant negotiation, business and financial principles, pharmaceutical product development process knowledge, CRO involvement understanding, eTMF management, stakeholder coordination
Preferred skills
Automated systems proficiency, risk analysis, regulatory compliance knowledge
Responsibilities
Draft and execute contracts with sites and PIs, negotiate budget and terms within parameters, coordinate stakeholder reviews, monitor contractual progress, upload finalized documents to eTMF, reduce regulatory/legal/financial exposure
Seniority
Mid-level IC (2-5 years experience)