Job Title: Associate II, TMF Operations
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The role of the Associate II, TMF Operations involves ensuring the management of essential documents. This position is responsible for processing, maintaining, and archiving these documents in compliance with regulatory requirements, industry best practices, and company standards.
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* Review and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats.
* Perform periodic quality control checks to ensure adherence to regulatory and industry standards.
* Utilize Electronic Document Management systems to review, classify, and process essential documents.
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Key Responsibilities:
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* Process and review TMF documents for complex studies or Sponsor portfolios.
* Conduct quality control checks on TMF documents to ensure accuracy and completeness.
* Communicate with team members regarding trends and issues related to TMF documents.
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Required Skills and Qualifications:
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* Proficiency in using electronic document repositories and eTMF systems.
* Strong interpersonal skills for working in a fast-paced environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
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Your Experience:
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* University degree preferred, particularly in life sciences.
* 1-2 years of relevant experience.
* Familiarity with working in a highly regulated industry is desirable.