(Contract) Trial Master File Administrator, Clinical Operations
Moderna is seeking a Trial Master Administrator to work across its projects as well as to work with the eTMF vendor and CROs. This position reports directly to the Moderna's Head of Therapeutic Operations. This position will work collaboratively across several therapeutic area teams for to ensure implementation, compliance and support of the eTMF for clinical trials conducted by Moderna.
- Participate in study team meetings and provide an overview of TMF status
- Set up eTMF for each clinical study and ensure ongoing compliance
- Develop and maintain system access rights and permissions
- Collaborate with internal and external team members to support implementation, on-going use and optimization of the eTMF and any additional new platforms in the future
- Provide internal communication of system access, training, updates and ongoing maintenance
- Participate in departmental initiatives aimed at improving process, efficiency and optimization of processes to the overall benefit of the Clinical Operations
- Responsible for maintaining Sponsor file readiness at all times for inspection by health authorities
- Ensure file readiness and provide technical support in preparation for site and incoming (including internal) audits.
- Ability to transition CRO TMF to the Moderna system and access for completeness
- Conduct targeted eTMF quality checks and audits as needed for ongoing studies
- May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed.
- Bachelor's degree in a science-based subject
- Minimum of 3 years of clinical research experience which must include TMF management
- Solid understanding of good Clinical GCP/ICH is required.
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors