TMF Operations Associate
The role of a TMF Operations Associate involves the processing, maintaining and archiving of all essential documents in compliance with regulatory requirements. This includes reviewing and resolving rejected Trial Master File (TMF) documents, performing periodic quality control to ensure adherence to industry best practices, and working with electronic document management systems.
Responsibilities:
* Process and review TMF documents for complex studies or sponsor portfolios.
* Perform quality control checks to ensure adherence to regulations and industry best practices.
* Work with electronic document management systems to review, classify and process essential documents.
* Communicate with project team members to report trends and issues relevant to the TMF.
Requirements:
* Proficiency in use of electronic document repositories and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
About the Role:
This is a global role that requires working with worldwide project team members. The ideal candidate will have proficiency in Microsoft Word and Excel, and knowledge of working within a highly regulated industry.
A university degree is preferred, and 1-2 years of relevant experience is required. The successful candidate will be able to work independently and as part of a team, and will have strong problem-solving skills.
This role is responsible for ensuring the management of essential documents, and will require the candidate to work in a fast-paced environment with deadlines.