Clinical Study Administrator coordinates and administers interventional clinical studies from initiation through closeout within a local study team. The role ensures quality delivery of study activities, regulatory compliance, and maintains electronic trial master files according to ICH-GCP standards.
Responsibilities
Coordinate study activities from startup through execution and closeout phases
Collect, prepare, review and track regulatory documents for EC/IRB submissions
Manage local electronic trial master file and investigator safety file maintenance
Interface with investigators, service providers and clinical research associates on document delivery
Support regulatory inspections, audits, and prepare administrative coordination materials
Requirements
Scientific degree supporting administrative and clinical capabilities
Prior administrative experience in medical or life science field
Proficiency with Veeva Clinical Vault, SAP S/4HANA, Coupa
Fluent spoken and written English
Strong organizational, time management, and attention to detail skills
Knowledge of clinical study processes and ICH-GCP guidelines preferred

📌 Sr. Medical Science Liaison - Obesity And Related Conditions - Pittsburgh Pa (Xico)
🏢 Amgen
📍 Xico