Clinical Trial Associate
Core
Support Phase 3 clinical trials by managing documentation, coordinating with CROs, and ensuring inspection readiness for regulatory submissions.
Role type
Clinical Trial Associate (Phase 3)
Builds
Clinical trial deliverables for regulatory approval
Domain
Biopharmaceuticals / Clinical Development
Required skills
Clinical trial execution, Trial Master File (TMF) management, CRO coordination, Regulatory compliance (GCP), Risk tracking, Documentation management
Preferred skills
Site activation, Protocol deviation analysis, Budget tracking, Study meeting organization
Technologies
eTMF, CTMS, MS Office
Responsibilities
Support global site activation, study conduct, and closeout; Manage TMF setup, maintenance, and QC; Collaborate with CROs on monitoring reports and KPIs; Coordinate regulatory documentation; Track timelines and escalate risks; Support clinical audit readiness; Maintain informed consent and protocol amendment tracking; Assist with vendor invoice reconciliation.
Seniority
Mid-level, hands-on IC
