Sr. Clinical Trial Manager, Clinical Operations, 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. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

Here’s What You’ll Do:

• 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 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: late stage experience, 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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick