Clinical Trial Associate
Core
Support execution of Phase 1-3 clinical trials, ensuring compliance with GCP standards and maintaining inspection-readiness for regulatory submissions.
Role type
Clinical Trial Associate (IC)
Builds
Clinical trial deliverables for pivotal studies supporting regulatory approval
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Clinical trial execution (Phase 1-3), Trial Master File (TMF) management, CRO collaboration, regulatory documentation review, risk tracking, vendor invoice reconciliation
Preferred skills
Site management and monitoring practices, protocol deviation identification, clinical drug development process understanding
Technologies
eTMF, CTMS, MS Office
Responsibilities
Support global site activation, study conduct, and closeout; Manage TMF setup, maintenance, and QC; Collaborate with CROs to review monitoring reports and KPIs; Coordinate trial activities with internal teams and vendors; Track progress against timelines and escalate risks; Support clinical audit readiness and regulatory filing preparation; Maintain informed consent and protocol amendment tracking; Assist in vendor invoice reconciliation and budget tracking
Seniority
Junior to Mid-level, hands-on IC
