TMF Operations Associate Role
The TMF Operations Associate plays a vital role in ensuring the efficient processing, maintenance, and archiving of essential documents in compliance with regulatory standards.
This global position requires collaboration with project team members to deliver department objectives.
* Process and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or sponsor portfolios.
* Conduct periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Utilize various Electronic Document Management systems to review, classify, and process Essential Documents.
* Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
* Escalate TMF Quality issues in a timely manner to the RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Essential Qualifications
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).
About This Role
This position is ideal for individuals who can work effectively in a dynamic environment and possess strong organizational skills. The successful candidate will be responsible for supporting the delivery of department objectives and ensuring the management of essential documents.