Job Description
We are seeking an Associate II, TMF Operations to join our team. The successful candidate will be responsible for the processing, maintaining and archiving of all essential documents in compliance with regulatory requirements.
The ideal candidate will have a strong understanding of document management systems and be able to work effectively in a fast-paced environment.
* Main Responsibilities
* Process, review and resolve rejected Trial Master File (TMF) documents.
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP and industry best practices.
* Work with electronic document management and electronic TMF systems to review, classify and process Essential Documents.
* Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
* Escalate any 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
* Education
* University Degree preferred (Life Science desirable)
* Skills and Qualifications
* Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
* Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
About the Role
This is a global role that requires working with Worldwide Project Team members. The successful candidate will have excellent communication and organizational skills.
What You Will Bring to the Role
* Knowledge of working within a highly regulated industry (desirable).
Your Experience
* 1-2 years of relevant experience.
About the Company
We are a company that values teamwork and collaboration. We offer a dynamic and supportive work environment.