Job Description:
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* As a TMF Operations Associate, you will play a crucial role in ensuring the management of essential documents.
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The Associate II, TMF Operations is responsible for processing, maintaining, and archiving all relevant documents in compliance with regulatory requirements and industry best practices. This global role requires collaboration with Worldwide Project Team members.
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Key Responsibilities:
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* Review and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats.
* 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 Lead to report trends and issues relevant to the TMF.
* Evaluate any TMF Quality issues in a timely manner and escalate them to RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
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Requirements:
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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.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
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Preferred Qualifications:
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* University Degree preferred, particularly in Life Sciences.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry.
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About the Role:
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This is a global opportunity that demands adaptability, strong communication skills, and a keen eye for detail.
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Contact Information:
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Please note that contact information has been removed from this job description.
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