**Job Overview**
This role involves the processing, maintenance, and archiving of essential documents in compliance with regulatory requirements and industry best practices.
The ideal candidate will support the delivery of department objectives by ensuring the management of essential documents is efficient and effective.
* Process, 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 electronic TMF Systems to review, classify, and process Essential Documents.
About the Role
This is a global position that requires collaboration with Worldwide Project Team members. The successful candidate will have strong interpersonal skills and be able to work effectively in a fast-paced environment.
The role involves communicating directly with RMC Leads to report trends and issues relevant to the TMF and escalating any TMF Quality issues in a timely manner.
Key Responsibilities:
* Administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
* Providing guidance on document recognition skills and proficiency in electronic document repositories or eTMFs.
Requirements
To be successful in this role, you will need:
* Proficiency in Microsoft Word and Excel.
* Strong analytical and problem-solving skills.
* A university degree in a Life Science or related field (desirable).
* 1-2 years of relevant experience in a highly regulated industry (desirable).
What You Will Bring
We are looking for a motivated individual who can:
* Demonstrate sound judgment and decision-making skills.
* Showcase excellent communication and interpersonal skills.
* Ability to work in a team environment and provide administrative support as needed.
Additional Information