Job Title: Document Control Specialist
About the Role:
This is an exciting opportunity to join our team as a Document Control Specialist, where you will play a critical role in ensuring the smooth operation of our document management system. As a key member of the team, you will be responsible for processing, maintaining and archiving essential documents in compliance with relevant regulations and industry best practices.
Key Responsibilities:
• Process and review Trial Master File (TMF) documents, including complex studies and Sponsor portfolios, in electronic and hard copy formats.
• Perform periodic Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
• Communicate directly with the RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to the RMC Lead.
• Provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint.
Your Skills and Qualifications:
• Proficiency in using 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.
What You Will Bring:
• University Degree preferred (Life Science desirable)
• 1-2 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable)