Job Description
The Associate II, TMF Operations is a critical role in ensuring the management of essential documents. This position requires strong organizational and communication skills to support the delivery of department objectives.
Main Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolios in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues in a timely manner to RMC Lead.
The ideal candidate will have proficiency in using an electronic document repository or eTMF, document recognition skills, and strong interpersonal skills in a fast-paced environment.
Requirements:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)