Counsel, Clinical Contracting
Core
Manage high-volume global clinical site agreements and related documents to support late-phase clinical studies.
Role type
Corporate Counsel (Clinical Contracting)
Builds
Clinical Trial Agreements, Master Clinical Trial Agreements, and regulatory support documents for clinical programs.
Domain
Biotechnology / Pharmaceutical / Clinical Research
Required skills
Global clinical trial contracting, contract negotiation, redlining, regulatory document review, workflow management, risk identification, template improvement
Preferred skills
US and international clinical site contracting, ICH-GCP/HIPAA/GDPR familiarity, CLM systems experience
Technologies
Contract Lifecycle Management (CLM) systems
Responsibilities
Lead end-to-end review, negotiation, and finalization of global clinical site agreements; Draft and negotiate clinical research agreements (CTAs, MCTAs, CDAs, ICFs, etc.); Serve as liaison between internal stakeholders and external partners (CROs, sites); Maintain tracking systems and manage document flow; Flag risks and non-standard terms; Suggest improvements to templates and workflows
Seniority
Mid-Senior, hands-on IC