Senior Contract Specialist
Core
Manages the preparation, negotiation, and finalization of Investigator Contracts with study sites, ensuring quality, objectivity, and risk analysis.
Role type
Senior Site Contract Specialist
Builds
Investigator Contracts for clinical study sites
Domain
Pharmaceutical/CRO industry, Contract Law
Required skills
Contract law principles, Investigator grant budget negotiation, Risk analysis, Pharmaceutical product development process knowledge, Contractual process compliance, Mentoring
Preferred skills
Country process improvement expertise, Training and mentoring staff, Automated systems usage
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.
Seniority
Senior, hands-on IC