Job Summary:
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The role of the Associate II, TMF Operations is to process, maintain and archive essential documents in compliance with regulatory requirements and industry best practices. This position supports the delivery of department objectives by ensuring the management of essential documents.
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Key Responsibilities:
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* Process and review Trial Master File (TMF) documents for complex studies or Sponsor portfolios in both electronic and hard copy formats.
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* Perform periodic Quality Control checks to ensure adherence to regulatory and industry standards.
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* Work with various Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
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* Communicate with RMC Lead to report trends and issues relevant to the TMF.
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* Evaluate and escalate any TMF Quality issues in a timely manner to RMC Lead.
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* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
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Required Skills and Qualifications:
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* Proficiency in using an electronic document repository or eTMF, and strong document recognition skills.
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* Strong interpersonal skills, with ability to work effectively in a fast-paced environment.
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* Sound judgment and ability to identify decisions requiring supervisory approval.
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* Proficiency in Microsoft Word and Excel.
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* University Degree preferred, with Life Science being desirable.
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* 1-2 years of relevant experience in a highly regulated industry.
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Your Experience:
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This role requires a combination of technical knowledge and business acumen, with the ability to adapt to changing priorities and deadlines. If you have a passion for detail and are committed to delivering high-quality results, we encourage you to apply for this exciting opportunity.