Job Description
We are seeking a highly skilled TMF Operations Associate II to join our team. This individual will be responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
As a TMF Operations Associate II, you will support the delivery of department objectives in ensuring the management of essential documents. This is a global role that requires working with Worldwide Project Team members.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
* 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.
* Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements:
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Qualifications:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience
* Knowledge of working within a highly regulated industry (desirable)