eTMF Manager

The Role: 
The Clinical Trial Systems Operations (CTSO) team at Moderna is looking for an agile, self-motivated, and experienced individual to be responsible for working across clinical trials to implement and execute on eTMF strategy, governance, and processes, and review/conduct quality checks of eTMFs and related documentation. This role will also manage filing and maintenance activities for clinical trials during the trial start-up, maintenance, and close-out periods.  The successful candidate will be detail-oriented with a flexible and solution-oriented outlook and the ability to support team members within Moderna and at our CRO partners. 

Here’s What You’ll Do:  

• Maintain effective communication with clinical trial teams, CRO staff, and eTMF vendor personnel throughout trial start-up, maintenance, and close-out.

• Support TMF document filing into Moderna eTMF system. 

• Author initial TMF plans and manages updates throughout the trial.

• Maintain a naming and filing guide specific to TMF documents.

• Perform routine quality checks of documents uploaded into the eTMF.

• Respond to inquiries regarding TMF management and contents.

• Attend departmental and trial-specific meetings and discussions, as required.

• Run routine eTMF reports and monitors TMFs for completeness and trends. Presents analysis and drives actions when identifying issues or negative trends.

• Oversee vendor and/or internal TMF operations team members assigned to your trials, escalating performance issues as appropriate.

• Where vendor support is used:

  • Provide input to budget forecasting as required (accruals and trial scope changes).

  • Provide input to contract provision/amendment as required.

  • Oversee invoicing on assigned trials.

• Support inspection and audit preparation and execution (front and back room as needed)

• Support system updates by participating in user acceptance testing and system enhancement discussions.

• Complete other TMF document-related tasks as required by the trial teams, your manager or more senior leadership in CTSO or Clinical Development Operations.

Here’s What You’ll Bring to the Table: 

• BA/BS required; Advanced degree preferred.

• 4+ years of experience in a clinical research environment within the pharmaceutical and biotech industry.

• 2+ years of eTMF document management experience.

• Clear and timely communication skills.

• Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements 

• Strong organizational/prioritization skills for the management of workload and attention to detail

• Demonstrated proficiency with eTMF applications

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!