Sr. Clinical Trial Manager, Therapeutics and Oncology

The Role

The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position may report to the Sr. Director/Director, Clinical Operations, Therapeutics and Oncology. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

• Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
• Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
• Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies
• Draft and/or oversee the drafting of site materials including training, manuals and support documentation
• Review clinical data to ensure timely entry and readiness for data review meetings
• Perform periodic review of clinical data, quality metrics and study deviations
• Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Review clinical monitoring reports to ensure timely completion and identification of issues
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
• Complete and maintain internal clinical trial metrics, dashboards and other internal updates
• Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
• Participate in testing of clinical trial systems/databases (i.e. UAT)
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
• May support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)
• Participate in clinical operations work streams related to departmental and operating model related initiatives Develop and maintain strong, collaborative relationships with key stakeholders within and external to Moderna
• Strive for continuous improvement and more efficient ways of working in clinical development
• Act as a role model for Moderna’s values

• 5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred
• Bachelor’s degree required;
  Advanced degree preferred
• Robust oncology/rare disease experience required. Desirable: immuno-oncology, high complexity such as CAR-T.
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Excellent verbal and written communication skills
• Good organizational skills and attention to detail

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.

• 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…