Job Description
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* As an Associate II, TMF Operations, you will be responsible for ensuring the management of essential documents in compliance with regulatory requirements.
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* You will work with various electronic document management systems to review, classify and process documents.
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* Your role will involve communicating directly with team members to report trends and issues relevant to the TMF.
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* You will also provide administrative support to the RMC Lead, including filing and maintaining internal documents.
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Key Responsibilities
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1. Process, review and resolve rejected Trial Master File (TMF) documents.
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2. Perform periodic TMF Quality Control to ensure adherence to regulatory and industry best practices.
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3. Work with electronic document management and eTMF systems to review and process Essential Documents.
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4. Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
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5. Evaluate and escalate any TMF quality issues in a timely manner.
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6. Provide administrative support for the RMC Lead, including filing and maintaining internal documents.
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Requirements
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* Proficiency in using electronic document repository or eTMF, and document recognition skills.
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* Strong interpersonal skills 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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Education and Experience
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* University Degree preferred (Life Science desirable).
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* 1-2 years of relevant experience.
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* Knowledge of working within a highly regulated industry (desirable).
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