Sr. Clinical Trial Manager, 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, Clinical Operations, Oncology.

Here’s What You’llDo

• 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
• Periodically review 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
• Support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)
• Participate in clinical operations workstreams 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

Here’s What You’ll Need (Basic Qualifications)

• 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 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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, 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 investment opportunities 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.

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.

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.