Senior Specialist
Worldwide Clinical Trials · Durham, NC
OtherFull-timeCompany career page
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Role summary
Worldwide Clinical Trials seeks a Senior Specialist to develop, review, and negotiate Site Agreements with clinical trial institutions and investigators. The role involves managing contracts throughout trial stages, coordinating with legal and regulatory teams, and ensuring compliance with international standards.
What they're looking for
- Advanced contract negotiation skills with clinical sites and vendors
- Thorough knowledge of FDA, EMA, and ICH-GCP regulatory requirements
- Excellent written and verbal communication abilities
- Proficiency with contract management software and tools
- Strong problem-solving and critical thinking capabilities
- Experience with budgeting and financial principles in clinical trials
What you'll be doing
- Draft, review, and negotiate Site Agreements and ancillary contracts with institutions
- Prepare country-specific contract templates and manage clinical trial agreement development
- Track contract execution timelines, budgets, and negotiation status across assigned sites
- Coordinate translations and communicate with legal, finance, and clinical operations teams
- Perform quality checks on contracts before finalization and manage execution through eTMF
Privacy & handoff
This role links to Worldwide Clinical Trials's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.