TMF Operations Associate Role Overview
The position of TMF Operations Associate plays a pivotal role in ensuring the seamless management of essential documents. This global role requires collaboration with Worldwide Project Team members to achieve departmental objectives.
* Responsibilities:
o Process and review rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or Sponsor portfolios.
o Conduct periodic TMF Quality Control checks to ensure compliance with regulatory, ICH GCP, Sponsor, and industry best practices.
o Work with various Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
o Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
o Elevate any TMF Quality issues to RMC Lead in a timely manner.
* Skills and Qualifications:
o Proficiency in using electronic document repositories or eTMFs, along with document recognition skills.
o Strong interpersonal skills in fast-paced environments with deadlines.
o Sound judgment and ability to identify decisions requiring supervisory approval.
o Proficiency in Microsoft Word and Excel.
Requirements and Expectations
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Familiarity with working within highly regulated industries (desirable)