Senior Clinical Project Manager

Role Summary

Senior Clinical Project Manager within our Clinical Operations team who will manage 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, but not limited to, 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 is required
• 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 involvement 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

Education

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

Additional Requirements

• Willingness and ability to travel to sites, conferences and Recursion offices as needed