Clinical Research

• Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial with a focus on late-stage trials
• 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 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
• 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
• 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
• Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities

Senior Clinical Trial Manager

Job Level

Tech Stack

About the role

Requirements