Document Manager for Clinical Trials
The role of a Document Manager in Clinical Trials is crucial in ensuring the accuracy and compliance of essential documents. This position involves processing, maintaining, and archiving all necessary documents in accordance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This global role requires collaboration with project team members to support the delivery of department objectives in managing essential documents. Key responsibilities include:
* Reviewing and resolving rejected Trial Master File (TMF) documents in both electronic and hard copy formats for complex studies or sponsor portfolios.
* Conducting periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Working with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
* Communicating directly with the RMC Lead to report trends and issues relevant to the TMF.
* Escalating any TMF Quality issues in a timely manner to the RMC Lead.
In addition to these responsibilities, administrative support will be provided for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements
* Proficiency in the use of an electronic document repository or eTMF and document recognition skills are essential.
* Strong interpersonal skills are required in a fast-paced, deadline-oriented environment.
* Sound judgment and the ability to identify decisions requiring supervisory approval are necessary.
* Proficiency in Microsoft Word and Excel is also required.
Qualifications
* A University Degree is preferred, particularly in Life Sciences.
* Relevant experience of 1-2 years is required.
* Knowledge of working within a highly regulated industry is desirable.