Clinical Systems Manager

Position Summary:

The Clinical Systems Manager for Trial Master File (TMF) System is responsible for overseeing a team of Documents Specialists collecting, reviewing, maintaining, and archiving essential clinical study documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The Clinical Systems Manager, TMF will provide oversight, support and back up the Document Specialists on one or more clinical programs. The Manager is also responsible for monitoring the performance of the system; documenting training, performance and enhancements; and ensuring overall completeness and inspection ready status of study eTMFs.

Essential functions of the job include but are not limited to:

Oversight & Quality (60%)

Staff Management (20%)

Document Management (10%)

Qualifications:

Minimum Required:

Other Required:

Competencies: