Job Summary:
This role focuses on the processing, maintenance, and archiving of essential documents to ensure compliance with relevant SOPs, ALCOA principles, country regulations, and industry best practices.
The successful candidate will support the delivery of department objectives in ensuring the management of essential documents, working closely with a global project team.
* Process and resolve rejected Trial Master File (TMF) documents in electronic and hard copy formats for complex studies or sponsor portfolios.
* Perform periodic TMF quality control to ensure adherence to regulatory, ICH GCP, sponsor, and industry standards.
* Collaborate with various electronic document management systems to review, classify, and process essential documents.
* Communicate trends and issues relevant to the TMF with RMC Lead, escalating quality concerns in a timely manner.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
About You:
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented environments.
* Sound judgment to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
Your Background:
* University degree preferred, Life Science desirable.
* 1-2 years of relevant experience.
* Knowledge of working within a highly regulated industry is a plus.