Job Description:
The Associate II, TMF Operations role is responsible for the processing, maintaining and archiving of all essential documents in compliance with relevant standards and regulations.
* 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, and industry best practices.
This position requires strong interpersonal skills in a fast-paced environment, with sound judgment and ability to identify decisions requiring supervisory approval.
Key Responsibilities:
* Review and process Essential Documents using Electronic Document Management systems.
* Communicate directly with RMC Lead to report trends and issues related to the TMF.
* Escalate TMF Quality issues in a timely manner to RMC Lead.
* Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Requirements:
* Proficiency in use of electronic document repositories and document recognition skills.
* Strong communication skills in a deadline-oriented environment.
* Sound judgment and decision-making skills.
* Proficiency in Microsoft Word and Excel.
About this Role:
This is a global role that requires working with Worldwide Project Team members. The ideal candidate will have a university degree in Life Science, 1-2 years of relevant experience, and knowledge of working within a highly regulated industry.