TMF Operations Associate Role
The TMF Operations Associate plays a crucial role in ensuring the efficient processing, maintaining and archiving of essential documents. This global position requires collaboration with project team members to deliver department objectives.
This role is ideal for individuals with proficiency in electronic document management systems, strong interpersonal skills and sound judgment. A university degree in a life science field is preferred, but not mandatory.
* Process and review Trial Master File (TMF) documents, both in electronic and hard copy formats, for complex studies or sponsor portfolios.
* Perform periodic quality control checks on TMFs to ensure adherence to regulatory, ICH GCP, sponsor and industry best practices.
* Utilize various electronic document management and eTMF systems to review, classify and process essential documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Elevate any TMF quality concerns in a timely manner to the RMC Lead.
Administrative support for the RMC Lead includes filing and maintaining internal documents on study SharePoint.
Key Requirements
* Proficiency in electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in fast-paced environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background
* University Degree in Life Science (preferable).
* 1-2 years of relevant experience.
* Familiarity with highly regulated industries (desired).
This is a fantastic opportunity to join our organization and contribute to the success of our team.