Job Summary
The Associate II, TMF Operations role is a key position in ensuring the management of essential documents. As a global role, this position requires collaboration with project team members to support department objectives.
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* Process and review trial master file (TMF) documents for complex studies or sponsor portfolios, both electronically and in hard copy format.
* Perform periodic quality control checks on TMFs to ensure adherence to regulatory, ICH GCP, and industry best practices.
* Work with electronic document management systems to review, classify, and process essential documents.
* Communicate with RMC Leads to report trends and issues relevant to TMFs.
* Escalate any TMF quality issues in a timely manner to RMC Leads.
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About You
* Proficiency in using an electronic document repository or eTMF, and document recognition skills are essential.
* You will possess strong interpersonal skills and be able to work in a fast-paced, deadline-oriented environment.
* Sound judgment and ability to identify decisions requiring supervisory approval are necessary.
* Proficiency in Microsoft Word and Excel is required.
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Your Qualifications
* A university degree is preferred, particularly in life sciences.
* Relevant experience of 1-2 years is required.
* Familiarity with working within a highly regulated industry is desirable.