Job Description
The role of the Senior Clinical Trial Administrator (Sr CTA) is to perform daily administrative activities and support the Project Manager(s), Project Director(s) and cross-functional study team(s) through expert knowledge and effective use of the systems, tools and processes available with a focus on a complete and accurate Trial Master File (TMF) delivery. Supports Project Support Specialist (PSS) in setting up and archiving eTMF(s).
THIS IS A HYBRID ROLE: WE EXPECT THE SUCCESSFUL CANDIDATE TO WORK IN THE OFFICE 2-3 DAYS PER WEEK
Specific Duties:
1. Administrative Support to the Project team: Support clinical trial teams in the planning, initiation, execution, and close-out of studies in compliance with ICH-GCP, SOPs, and regulatory requirements.
2. TMF Management: Maintain and update the Trial Master File (TMF/eTMF) to ensure inspection-readiness at all times. –
3. CPTMS Management: Manage and support the Clinical Trial Management System (CTMS), ensuring accurate and timely data entry, updates, and reporting.
4. Project Tracking: Coordinate and track study documents, contracts, and essential trial correspondence.
5. Assist with the preparation and review of study-related materials, including site binders, tracking logs, and meeting minutes.
6. Coordination of study specific training in the Learn...