**Job Title:** Document Management Specialist
About the Role:
We are seeking a highly organized and detail-oriented Document Management Specialist to join our team. In this role, you will be responsible for processing, maintaining, and archiving essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities:
* Document Processing: You will process and review Trial Master File (TMF) documents in both electronic and hard copy formats, resolving any issues or discrepancies that arise during the process.
* TMF Quality Control: Perform periodic quality control checks to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices.
* Electronic Document Management: Work with various electronic document management systems to review, classify, and process essential documents.
* Communication: Communicate directly with RMC Leads to report trends and issues related to TMF.
* Issue Escalation: Escalate any TMF quality issues in a timely manner to RMC Leads.
* Administrative Support: Provide administrative support to RMC Leads, including filing and maintaining internal documents on study SharePoint.
Requirements:
* Education: University degree preferred, with a focus on life sciences desirable.
* Experience: 1-2 years of relevant experience, preferably in a highly regulated industry.
* Skills: Proficiency in electronic document repository software, document recognition skills, strong interpersonal skills, sound judgment, and proficiency in Microsoft Word and Excel.
About Us:
We offer a dynamic and supportive work environment that encourages growth and development. If you are a detail-oriented and organized individual with excellent communication skills, we encourage you to apply for this exciting opportunity.