Job Description
Job Description
Under the oversight of the CRA manager, provide administrative and operational support to clinical study teams, with a focus on monitoring Key Projects Indicators, maintaining Trial Master File quality and completeness. Collaborate cross-functionally to drive process improvements and ensure compliance with internal standards and regulatory requirements.
Key Responsibilities
- Support the drafting of progress reports for submission/notification to the MoH
- Monitor KPIs (primarily within the eTMF), generate periodic reports, and escalate issues as appropriate.
- Reconcile and monitor documents uploaded to external team platforms versus those filed in the eTMF, ensuring alignment and completeness.
- Support the follow-up and collection of essential documents required for timely upload to the eTMF, maintaining quality and version control.
- Run SUSAR reports and share status updates with CRAs; support oversight of safe...
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