The Role: The Manager, TMF Sytems and Operations plays a key role in supporting the daily operations and maintenance of Moderna's Clinical Trial Management System (CTMS), eTMF system and Trial Master File (TMF). This role ensures study systems are properly configured, maintained, and compliant with regulatory and company standards.
The Manager partners with study teams, CROs, and vendors to ensure accurate, complete, and inspection-ready data and documents throughout the study lifecycle. This position is responsible for supporting CTMS and eTMF activities, executing operational processes, and assisting with system enhancements and training initiatives.
Here's What You'll Be Doing:CTMS Operations- Execute day-to-day CTMS operational activities, including study/country/site creation, user provisioning, and workflow management.
- Ensure CTMS data is complete, accurate, and up to date for milestones, visits, issues, and site information.
- Support the development and delivery of standard reports and dashboards for study teams and leadership.
- Assist with system updates, releases, and UAT activities, including test execution and documentation.
- Collaborate with IT and external partners to troubleshoot and resolve user or data issues.
TMF Records Management- Support TMF setup and maintenance throughout the study lifecycle.
- Ensure documents are filed accurately and on time in the eTMF according to company SOPs and the TMF Reference Model.
- Conduct TMF health checks, reconciliation, and quality review activities across assigned studies.
- Serve as TMF Lead sitting on the clinical trial team, ensuring compliance, quality, and inspection readiness.
- Work with CROs and internal teams to address TMF quality or completeness issues.
- Provide guidance to study teams on document filing expectations and metadata accuracy.
- Provide end-user training and office hours on eTMF best practices
Data Quality & Compliance- Maintain CTMS and TMF data accuracy and consistency across systems.
- Support reconciliation activities between CTMS and eTMF (e.g., milestone vs. document matching, site activation vs. essential documentation).
- Monitor operational metrics and identify data discrepancies for correction.
- Contribute to ensuring inspection readiness across assigned studies and systems.
Audit & Inspection Support- Assist in audit and inspection preparation activities by ensuring documentation and data are current, accurate, and easily retrievable.
- Participate in mock inspections, inspections, and readiness checks as assigned.
- Support the resolution and documentation of any findings related to CTMS or TMF.
Cross-Functional & Vendor Collaboration- Partner with functional contributors which may include - Clinical Operations, Data Management, Regulatory, and QA to support delivery of CTMS/eTMF milestones.
- Liaise with CROs and vendors to monitor TMF quality and resolve operational issues.
- Collaborate with IT partners to support integrations and troubleshoot technical issues.
Process Improvement & Training- Identify opportunities for process and system improvements and share feedback with leadership.
- Contribute to updates of SOPs, work instructions, and templates related to CTMS and eTMF operations.
- Support the development and delivery of end-user training and onboarding sessions.
Here's What You'll Need (Basic Qualifications):- Bachelor's degree or equivalent work experience required.
- A minimum of 6 years of experience in clinical research or a related field, with at least 3 years of hands-on experience in TMF and/or CTMS operations.
- Working knowledge of Veeva Vault Clinical Suite (CTMS and eTMF) preferred.
- Familiarity with ICH GCP and global clinical documentation requirements.
- Strong attention to detail and ability to manage multiple priorities effectively.
- Excellent communication and organizational skills with the ability to work cross-functionally.
- Experience supporting audits or inspections preferred.
Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
