Job Title
Clinical Documentation Specialist
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About the Role
We are seeking a seasoned Clinical Documentation Specialist to join our vaccine development team.
* Set up, oversee, and lock clinical trial master files for assigned studies.
* Ensure high-quality trial master files are ready for inspection at any time.
* Lead kick-off meetings with clinical teams and CROs to ensure seamless collaboration.
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Key Responsibilities
1. Develop, maintain, and update trial master file plans throughout the study lifecycle.
2. Monitor trial master file quality and completeness, providing metrics, reports, and remediation plans as needed.
3. Provide guidance, support, and oversight to junior colleagues to ensure their success.
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About You
As a Clinical Documentation Specialist, you will bring strong experience in clinical documentation and trial master file management. You will balance detail and strategy while driving compliance and efficiency.