Contract Specialist - FSP
Core
Prepare, negotiate, and finalize contracts and budgets with clinical research study sites to ensure efficient study startup and risk management.
Role type
Site Contract Specialist (Clinical Research)
Builds
Clinical Trial Agreements, investigator grant budgets, payment terms, and ancillary agreements for pharmaceutical and biotech clients.
Domain
Pharmaceutical industry / Clinical Research / Contract Law
Deliverable
client delivery
Required skills
Clinical Trial Agreement (CTA) negotiation, investigator grant budget negotiation, fair market value analysis, clinical study protocol understanding, FDA/ICH-GCP guidelines knowledge, contract law principles, risk analysis, data-driven decision making
Preferred skills
Experience with CROs and TAU partners, knowledge of local tax and stamp laws, automated systems proficiency
Technologies
Automated contract systems, computerized applications
Responsibilities
Draft, review, and negotiate agreements with study sites; manage budget negotiations and payment terms; partner with Study Startup and Clinical Operations teams; track actions to ensure timeline achievement; escalate potential delays and resolve site activation issues.
Seniority
Mid-level, hands-on IC