Job Title: Document Control Specialist - TMF Operations
About the Role
This role is responsible for ensuring the integrity and compliance of essential documents within the organization.
The Document Control Specialist will process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats. They will also perform periodic quality control checks to ensure adherence to regulatory requirements and industry best practices.
Key Responsibilities:
* Process and review TMF documents for complex studies and Sponsor portfolios
* Perform quality control checks on TMF documentation
* Work with electronic document management systems to review and classify essential documents
* Communicate with RMC Lead regarding trends and issues related to TMF
* Educate team members on proper document control procedures
Requirements
To be successful in this role, you should have a strong understanding of document control processes and regulations. Proficiency in Microsoft Word and Excel is required, as well as excellent communication skills and attention to detail.
Desirable qualifications include a university degree in a life science field and 1-2 years of relevant experience working in a highly regulated industry.
We are looking for a motivated individual who is passionate about document control and is committed to ensuring the accuracy and integrity of our records.
Working Environment
This is a global role that requires collaboration with team members worldwide. The successful candidate will work in a fast-paced environment and must be able to prioritize tasks effectively and meet deadlines.