Clinical Document Management Specialist

Job Summary

A company is looking for a Clinical Document Management Specialist to support clinical trials by managing essential study documents.

Key Responsibilities

• Provide operational and administrative guidance for the study TMF/eTMF, including setup, organization, maintenance, and close-out
• Collaborate with Clinical Study teams to ensure proper submission and filing of clinical study documents
• Perform quality control of the TMF/eTMF and maintain filing records for compliance with SOPs and regulatory guidelines

Required Qualifications

• Bachelor's degree with 1+ years of clinical operations experience in pharma, biotech, or CRO; or High School diploma with 4+ years of relevant experience
• Preferred experience with Trial Master File (TMF)
• Knowledge of ICH and GCP guidelines
• Proficiency in MS Word, Excel, PowerPoint, and Outlook
• Ability to work independently and adapt to changing priorities