Job Summary
We are seeking an experienced Associate II to join our team in TMF Operations. This role is 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. The successful candidate will support the delivery of department objectives in ensuring the management of essential documents, working closely with a global project team.
Key Responsibilities
* Process, review and resolve rejected Trial Master File (TMF) documents for complex studies or Sponsor portfolio of studies both in 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 filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in use of 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 (Life Science desirable).
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry (desirable).