Job Description
* We are seeking a detail-oriented and organized professional to support the processing, maintaining, and archiving of essential documents in compliance with regulatory requirements.
Responsibilities:
* Process and review Trial Master File (TMF) documents in both electronic and hard copy formats, resolving complex issues as needed.
* Perform periodic TMF Quality Control to ensure adherence to regulatory standards and industry best practices.
* Collaborate with various Electronic Document Management systems and eTMF platforms to review, classify, and process Essential Documents.
* Communicate directly with stakeholders to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues in a timely manner.
* Provide administrative support for the lead, including filing and maintaining internal documents on study SharePoint.
Requirements:
* Proficiency in using electronic document repositories or eTMFs, with strong document recognition skills.
* Excellent interpersonal skills, able to work effectively in a fast-paced environment.
* Sound judgment, with ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Qualifications:
* University degree preferred, with life science background desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is an asset.