ETMF Specialist Position
We are seeking a highly skilled eTMF Specialist to join our team. As an eTMF Specialist, you will play a crucial role in ensuring the efficient management of trial master file (TMF) documentation and statistics.
The ideal candidate will have significant experience in a similar job in the industry or CRO, with a solid understanding of clinical data management, statistical processes, and related documentation standards.
Key responsibilities include:
* Leading the documentation and data archiving team, recruiting, mentoring, and developing team members
* Training DM/STAT CRO on company standards and TMF-related activities
* Maintaining quality and timelines through regular checks and audits
To succeed in this role, you should possess excellent project management skills, knowledge of international data standards (CDISC), and regulatory requirements for data submission. A strong background in SAS System and ICH GCP is also essential.
This is a dynamic opportunity for an experienced professional to take on new challenges and contribute to the growth of our organization.