
Clinical Systems Specialist
1 day ago
Job Overview
The Senior Clinical Systems Specialist oversees the effective execution of clinical trials and programs. This role requires an individual with extensive experience in eClinical systems, particularly in maintaining the quality of the Trial Master File (TMF).
Key Responsibilities
- Conduct TMF quality reviews to ensure accuracy and completeness of document content and metadata.
- Perform periodic quality reviews for each active study site for regulatory documents.
- Compile and review regulatory documents for FDA submissions using GCP and ICH guidelines.
- Develop and implement TMF Quality plans and reports.
- Communicate filing issues to the manager for further evaluation.
- Collaborate with Study Owners on start-up, maintenance, and close-out activities related to the TMF.
- Manage user access and create/maintain events/placeholders in the eTMF.
- Identify and report trending issues/concerns, determining resolutions and course of action.
- Support metrics and report preparation for TMF Key Performance Indicators (KPIs) - completeness, quality, and timeliness.
- Storyboard support and maintenance to assist with inspection readiness.
- Enter and analyze CTMS data on behalf of clients.
- Lead and mentor eClinical Analysts.
- Complete other tasks assigned by the manager/supervisor.
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