Clinical Study Administrator
Core
Administrative support for interventional study deliverables, ensuring quality, consistency, and adherence to time, cost, and quality objectives across 5-7 projects.
Role type
Clinical Study Administrator
Builds
Regulatory documentation and research center archives for interventional studies
Domain
Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research experience, Regulatory document management, eTMF/ISF maintenance, Electronic document system management (ANGEL), Submission standards compliance (SRS), ICH-GCP knowledge
Preferred skills
Degree in Biology, Biochemistry, Pharmacy, Nutrition, Biotechnology, or related health field
Responsibilities
Coordinate and administer clinical studies from initiation to execution and close-out; Collect, prepare, review, and track documents for regulatory submissions; Interface with investigators, external service providers, and CRAs; Configure and maintain local eTMF and ISF; Ensure study documents are ready for final archiving; Create and import clinical-regulatory documents into global electronic management systems; Support electronic submissions meeting technical standards.
Seniority
Individual Contributor
