Job Summary
The TMF Quality Specialist is responsible for executing thorough quality control evaluations of clinical documentation, with the aim of ensuring adherence to both regulatory standards and internal standard operating procedures (SOPs). This role also involves participating in the enhancement of oversight processes and serving as a Business Process Owner to support system improvements.
Responsibilities
- Conduct detailed quality control reviews of clinical documents to verify compliance with regulatory guidelines and internal procedures.
- Assist in the development and refinement of oversight processes for clinical documentation.
- Support system enhancements and improvements, acting in the capacity of Business Process Owner.
Qualifications
- A minimum of 5 years of experience in operations related to Trial Master File (TMF).
- Extensive practical experience with Veeva Vault eTMF.
- A profound understanding of International Council for Harmonisation (ICH), Good Clinical Practice (GCP), and clinical documentation standards.
- Knowledge of relevant regulatory requirements that govern clinical documentation.
