Job Title:
* Document Control Specialist
About the Role:
The Document Control Specialist is responsible for ensuring the accurate processing, maintenance, and archiving of essential documents in accordance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
This role supports the delivery of department objectives by guaranteeing the management of essential documents. It is a global position requiring collaboration with Worldwide Project Team members.
Key Responsibilities:
1. Review and resolve rejected Trial Master File (TMF) documents, both in electronic and hard copy formats, for complex studies or Sponsor portfolios.
2. Conduct periodic TMF Quality Control to verify adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
3. Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
4. Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
5. Educate RMC Lead on any TMF Quality issues in a timely manner.
6. Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
Requirements:
1. Proficiency in using an electronic document repository or eTMF, along with document recognition skills.
2. Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment.
3. Sound judgment and ability to identify decisions requiring supervisory approval.
4. Proficiency in Microsoft Word and Excel.
Your Background:
* A university degree is preferred, with a Life Science background being desirable.
* 1-2 years of relevant experience.
* Familiarity with working within a highly regulated industry is desirable.