Job Summary:
We are seeking a detail-oriented Associate II to join our team in TMF Operations. The ideal candidate will have experience with electronic document management and excellent communication skills.
* Main Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices.
* Work with various Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate with the RMC Lead to report trends and issues relevant to the TMF.
* Escalate any 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.
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Desired Qualifications:
* University Degree (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.