Manager, TMF Systems and Operations

The Role:

The Manager TMF Sytems and Operations plays a key role in supporting the daily operations and maintenance of Modernas 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.

Heres What Youll 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.

Heres What Youll Need (Basic Qualifications):

• Bachelors 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. Thats why our benefits and well-being resources are designed to support youat 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

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 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 persons 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 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

Were 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 .

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