TMF & CTMS Operations Lead

BioSpace; Cambridge (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits (fertility/ad

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Manager of TMF Systems and Operations to oversee CTMS/eTMF operations and TMF records throughout the clinical trial lifecycle. You will partner with study teams, CROs, and vendors to ensure data accuracy, inspection readiness, and compliant documentation.

The role includes implementing system updates, training, and process improvements, with a focus on data quality and regulatory compliance across global studies. A strong background in TMF/CTMS and Veeva Vault is preferred.

Qualifications

• Bachelor’s degree or equivalent work experience.
• Minimum of 6 years of experience in clinical research or a related field, with at least 3 years 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.
• Excellent communication and organizational skills with the ability to work cross‑functionally.
• Experience supporting audits or inspections preferred.

Responsibilities

• 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 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.
• Support TMF setup and maintenance throughout the study lifecycle.
• Ensure documents are filed accurately and on time in the eTMF according to SOPs and TMF Reference Model.
• Conduct TMF health checks, reconciliation, and quality review activities across studies.
• Serve as TMF Lead 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 on document filing expectations and metadata accuracy.
• Provide end‑user training and office hours on eTMF best practices.
• Maintain CTMS and TMF data accuracy and consistency across systems.
• Support reconciliation between CTMS and eTMF (milestone vs. document matching, etc.).
• Monitor operational metrics and identify data discrepancies for correction.
• Contribute to inspection readiness across studies and systems.
• Assist in audit and inspection preparation activities and participate in mock inspections and readiness checks.
• Support resolution and documentation of findings related to CTMS or TMF.
• Partner with Clinical Operations, Data Management, Regulatory, and QA to support CTMS/eTMF milestones.
• Liaise with CROs and vendors to monitor TMF quality and resolve issues.
• Collaborate with IT to support integrations and troubleshoot technical issues.
• Identify opportunities for process and system improvements and share feedback with leadership.
• Contribute to updates of SOPs, work instructions, and templates for CTMS/eTMF operations.
• Support development and delivery of end‑user training and onboarding sessions.

Skills

Attention to detail

Cross-functional collaboration

Communication

Education

Bachelor’s degree

Tools

Veeva Vault CTMS/eTMF

Job description

Moderna is seeking a Manager of TMF Systems and Operations to oversee CTMS/eTMF operations and TMF records throughout the clinical trial lifecycle. You will partner with study teams, CROs, and vendors to ensure data accuracy, inspection readiness, and compliant documentation.

The role includes implementing system updates, training, and process improvements, with a focus on data quality and regulatory compliance across global studies. A strong background in TMF/CTMS and Veeva Vault is preferred.