Job Overview
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This role is responsible for the processing, maintenance, and archiving of essential documents in compliance with regulatory requirements, industry best practices, and organizational standards.
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Key Responsibilities
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* Process, review, and resolve rejected Trial Master File (TMF) documents, both 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 Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues relevant to the TMF.
* Evaluate and escalate TMF Quality issues in a timely manner to RMC Leads.
* Provide administrative support to RMC Leads, including filing and maintaining internal documents on study SharePoint.
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Requirements and Qualifications
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* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced environment with multiple deadlines.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
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Desired Background
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* University Degree preferred, particularly in Life Sciences.
* 1-2 years of relevant experience working within a highly regulated industry.