Associate II, TMF Operations Job Description
About the Role:
The Associate II, TMF Operations is responsible for ensuring the management of essential documents in compliance with relevant SOPs, ALCOA principles, country regulations, and industry best practices. This role involves working with a Worldwide Project Team to support the delivery of department objectives.
Key Responsibilities:
* Process, review, and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or Sponsor portfolios.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry standards.
* Work with 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 filing and maintaining internal documents on study SharePoint.
Required Skills and Qualifications:
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Education and Experience:
* University Degree preferred, with Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry, desirable.