Job Title: TMF Document Coordinator
About the Role
The TMF Document Coordinator is responsible for ensuring the integrity and compliance of Trial Master File (TMF) documents. This involves processing, reviewing, and resolving rejected documents in both electronic and hard copy formats.
This global role requires working closely with project team members to achieve department objectives and ensure effective management of essential documents.
Key Responsibilities
* Process and review TMF documents, including complex studies or sponsor portfolios, to ensure adherence to regulatory requirements and industry best practices.
* Perform periodic quality control checks on TMF documents to identify trends and issues.
* Work with electronic document management systems and eTMF platforms to classify, process, and maintain essential documents.
* Communicate directly with stakeholders to report on TMF quality issues and provide administrative support as needed.
* Evaluate and escalate any TMF quality issues in a timely manner.
Requirements
To succeed in this role, you will need:
* Proficiency in using electronic document repositories and eTMF systems.
* Strong interpersonal skills and ability to work in a fast-paced environment.
* Sound judgment and decision-making skills.
* Proficiency in Microsoft Office applications, particularly Word and Excel.
Preferred Qualifications
A university degree in a life science field is preferred, along with relevant experience in a highly regulated industry.