Senior Clinical Project Manager

Role Summary

Senior Clinical Project Manager responsible for managing the conduct and execution of one or more clinical trials from study start-up to study closure with support or direction from a Director of Clinical Operations.

Responsibilities

• Lead all aspects of clinical trial execution for one or more programs from IND through proof-of-concept and pivotal studies
• Plan and oversee implementation, coordination, and execution of global clinical trials including oversight of study budgets, financial reporting, and forecasting in collaboration with Clinical Outsourcing
• Develop and maintain strong relationships with cross-functional study teams, CROs, clinical investigators, and clinical trial stakeholders
• Manage clinical trial operations and lead study teams, including CROs and vendors, and reporting of start-up, conduct, and close-out activities
• Ensure compliance with study protocol and applicable Standard Operating Procedures (SOP), Good Clinical Practices (GCP), ICH and local regulations

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field
• 7+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 3+ years experience in a clinical project management role within a biotech organization
• Early phase (Phase 1, 2) oncology experience at a biotech/Sponsor
• Demonstrated experience organizing and leading clinical study teams
• Preferred Skills: proficiency managing timelines, tasks, milestones in SmartSheet or similar project management software
• Demonstrated track-record of efficient and effective clinical trial planning and execution, including risk management and mitigation strategies
• Experience in vendor and CRO selection, management, and oversight
• Experience managing and tracking study budgets and financials with participation in invoice and contract review and approvals
• Experience working closely with data management and clinical teams to set up study systems and ensure quality data collection through monitoring, cleaning and analysis
• Preferred: CRF development and IRT build experience, knowledge of data listings used for monitoring and cleaning, contribution to data management related plans and specifications
• Excellent working knowledge of FDA, ICH, GCP regulations and guidelines
• Willingness and ability to travel to sites, conferences and Recursion offices as needed

Skills

• Clinical project management
• Vendor and CRO management
• Budgeting and financial planning
• Cross-functional team leadership
• Regulatory knowledge (FDA, ICH, GCP)
• Data management collaboration
• Project management software proficiency

Education

• Bachelor’s degree in a scientific or healthcare-related field