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Clinical Documentation Specialist
2 tygodni temu
About the Role
We are seeking a highly skilled Clinical Documentation Specialist to join our team at IQVIA. As a key member of our organization, you will be responsible for ensuring the efficient and effective management of Trial Master Files (TMFs) and other related documents.
Main Responsibilities
- Drive TMF quality at the trial level by acting as a single point of contact (SPOC) and business partner for clinical teams and regulatory bodies. Collect and understand requests, work with other roles/teams, and follow through to resolution.
- Provide subject matter expertise to ensure compliance with TMF processes and tools, and promote awareness of the importance of high-quality TMFs.
- Support the definition and refinement of the document management strategy for TMFs within assigned clinical trials teams.
- Promote best documentation practices to line functions and provide guidance on document standards to support inspection readiness and adherence to Good Documentation Practice.
Key Performance Indicators
- Ensure inspection-ready submission relevant documentation with no critical audit or inspection findings on formal TMF document compliance aspects.
- Meet timeliness requirements for TMF review, per key milestones as per process.
- Guarantee completeness of TMF review, including document availability and signposts.
- Deliver timely and high-quality provision of new or updated document management standards and guidance documents.
