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Cambridge, Massachusetts, United States
Hybrid
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 & Benefits
At 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.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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