Job Title: TMF Operations Associate
About the Role
The TMF Operations Associate plays a crucial role in ensuring compliance with regulatory standards, industry best practices, and company policies. This position is responsible for processing, maintaining, and archiving essential documents.
This global role requires collaboration with Worldwide Project Team members to achieve departmental objectives.
Key Responsibilities
* TMF Document Processing: Review, classify, and process electronic and hard copy Trial Master File (TMF) documents for complex studies or Sponsor portfolios.
* Quality Control: Perform periodic Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Electronic Document Management: Work with various Electronic Document Management systems to review, classify, and process Essential Documents.
* Communication: Report trends and issues relevant to the TMF to RMC Lead and escalate any Quality issues in a timely manner.
* Administrative Support: Provide administrative support to the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency: Proficient in using an electronic document repository or eTMF, and document recognition skills.
* Interpersonal Skills: Strong interpersonal skills in a fast-paced, deadline-oriented environment.
* Judgment: Sound judgment and ability to identify decisions requiring supervisory approval.
* Technical Skills: Proficient in Microsoft Word and Excel.
Preferred Qualifications
* Education: University Degree preferred, Life Science desirable.
* Experience: 1-2 years of relevant experience.
* Regulated Industry Knowledge: Knowledge of working within a highly regulated industry desirable.