TMF Operations Associate Role Summary
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The TMF Operations Associate plays a pivotal role in ensuring the smooth management of Trial Master File (TMF) documents, adhering to regulatory and industry best practices. This global position requires collaboration with worldwide project team members to deliver department objectives.
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Key Responsibilities:
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* Processing, reviewing, and resolving rejected TMF documents in electronic and hard copy formats for complex studies or sponsor portfolios.
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* Performing periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
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* Working with various Electronic Document Management and eTMF Systems to review, classify, and process essential documents.
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* Communicating directly with RMC Lead to report trends and issues relevant to the TMF.
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* Escalating any TMF Quality issues in a timely manner to RMC Lead.
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* Providing administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
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Required Skills and Qualifications:
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* Proficiency in using an electronic document repository or eTMF, and document recognition skills.
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* Strong interpersonal skills in a fast-paced, deadline-oriented 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 (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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About You:
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* A detail-oriented individual with excellent organizational skills.
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* Able to work effectively in a team environment.
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* Excellent communication and problem-solving skills.
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* Adaptable and flexible in a rapidly changing environment.
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