Job Description
We are seeking a highly skilled eTMF Specialist to join our team. As an eTMF Specialist, you will be responsible for ensuring data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
Key Responsibilities:
* To oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and audit readiness.
* To lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team members.
* To ensure providers match performance expectations.
* To promote optimal use of tools and metrics related to documentation management.
Requirements:
* A scientific degree.
* A significant experience in a similar job in the industry or CRO.
* Solid knowledge of clinical data management and statistical process and related documentation, standards and tools.
* Strong knowledge of international standards for Trial Master File (TMF Reference Model).
* Knowledge of ICH GCP and regulatory requirements with specific reference to data integrity, data archiving and document management.
Required Skills and Qualifications
The ideal candidate should have a strong background in clinical data management and statistical process, with a solid understanding of international standards for Trial Master File (TMF Reference Model) and regulatory requirements.
Benefits
This role offers the opportunity to work in a dynamic environment and contribute to the success of our team.
Others
Please note that this is a maternity replacement contract.