About the Role
We are seeking a highly skilled Associate to join our team in TMF Operations.
* The successful candidate will be responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities
The Associate II, TMF Operations will support the delivery of department objectives by ensuring the management of essential documents. This is a global role that requires working with project team members.
* 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 best practices.
* Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues relevant to the TMF.
* Escalate TMF Quality issues in a timely manner to RMC Leads.
* Provide administrative support for RMC Leads, including filing and maintaining internal documents on study SharePoint.
Requirements
* 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.
About You
We are looking for candidates with:
* A University Degree, preferably in Life Sciences.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.