eTMF Manager, Clinical Development

Company: SRG
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Job Overview

eTMF Manager, Clinical Development

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow's world.

Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The eTMF Manager, Clinical Development to be responsible for working across clinical study teams to design and implement eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and TMF documentation across the portfolio. This role will also manage filing and maintenance activities for clinical trials during the study start-up, maintenance and close-out periods.

Here's What You'll Do

• Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance and close-out
• Supports TMF document filing into eTMF system
• Maintains a naming and filing guide specific to TMF documents
• Performs routine quality checks of documents uploaded into the eTMF
• Responds to inquiries regarding TMF management and contents
• Attends departmental and study-specific meetings and discussions, as required
• Runs routine eTMF reports and monitors TMFs for completeness and trends
• Completes other TMF document-related tasks as required by the study teams or the Clinical Operations department
  Here's What You'll Bring To The Table
  
  • Life sciences degree or certification in a related allied health profession from an accredited institution (e.g., nursing, medical or laboratory technology) or equivalent5+ years experience in clinical trials (e.g., study coordinator, regulatory operations) and eTMF document management experience
  • Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements
  • Demonstrated proficiency with eTMF applications (Veeva Vault Clinical eTMF experience a plus), word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
    SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
    

Keywords: SRG, Cambridge , eTMF Manager, Clinical Development, Healthcare , Cambridge, Massachusetts