Job Summary
We are seeking a highly skilled Associate II to join our team in TMF Operations. This role involves processing, maintaining and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practices.
The ideal candidate will have a strong understanding of electronic document management systems and eTMF software. They will also possess excellent communication skills and be able to work effectively in a fast-paced environment.
Key Responsibilities
* TMF Document Processing
o Process and review Trial Master File (TMF) documents in electronic and hard copy formats
o Resolve rejected TMF documents for complex studies or Sponsor portfolios
* Quality Control
o Perform periodic TMF Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor and industry best practices
* eTMF System Management
o Review, classify and process Essential Documents using Electronic Document Management and eTMF Systems
* Communication and Reporting
o Communicate directly with RMC Lead to report trends and issues related to the TMF
o Escalate TMF Quality issues in a timely manner to RMC Lead
* Administrative Support
o Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint
Requirements
* Education
o University Degree preferred, with Life Science being desirable
* Experience
o 1-2 years of relevant experience
* Skill Set
o Proficiency in use of an electronic document repository or eTMF
o Document recognition skills
o Strong interpersonal skills in a fast-paced, deadline-oriented environment
o Sound judgment and ability to identify decisions requiring supervisory approval
o Proficiency in Microsoft Word and Excel
Working Environment
This is a global role that requires working with Worldwide Project Team members.
About Us
Our organization values teamwork, integrity and customer satisfaction.