About the role
Evaluate clinical-trial planning, site operations, protocol execution, monitoring, and inspection-readiness decisions across drug-development programs. Review AI-generated recommendations for feasibility, patient safety, data integrity, protocol compliance, and sponsor or CRO oversight. Identify operational assumptions, missing documentation, escalation gaps, and site-management decisions that conflict with ICH-GCP practice. Provide clear corrections that reflect how experienced clinical-operations leaders balance timelines, quality, and participant protection. Remote, project-based contract work. Scope and hours depend on project matching; the listed hourly range applies to matched work.
What we're looking for
- 8+ years in sponsor, CRO, or site-level clinical operations
- Deep knowledge of ICH-GCP, trial monitoring, site management, and protocol-deviation handling
- Clinical program leadership or inspection-readiness experience preferred