Job Description
The Associate II, TMF Operations plays a vital role in ensuring the management of essential documents in compliance with regulatory requirements and industry best practices.
This global role requires collaboration with Worldwide Project Team members to deliver department objectives.
Key Responsibilities:
* Process and review 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 best practices.
* Utilize Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate trends and issues relevant to the TMF with RMC Lead.
* Elevate TMF Quality issues to RMC Lead in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Required Skills and Qualifications
To excel in this role, you will need:
Technical Skills:
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Familiarity with Microsoft Word and Excel.
Soft Skills:
* Strong interpersonal skills in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
Education:
* University Degree preferred (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).