Clinical Trial Manager

Obsidian Therapeutics is seeking a Clinical Trial Manager to oversee early phase cell therapy oncology clinical trials. The successful candidate will facilitate collaboration with internal and external study teams, ensure patient recruitment, timelines, quality standards, Good Clinical Practices, and applicable regulations are met throughout all stages of the study.

Requirements

• BS/BA/RN Degree with 8+ years of experience in a life science or a health-related field is preferred.
• Minimum of 5+ years working on phase I-IV clinical studies, ideally at a sponsor, CRO or clinical study site in management of oncology, rare disease, or cell/gene therapy trials
• Strong understanding of regulatory (e.g., ICH-GCP, FDA and EU regulations) and Compliance requirements
• Biotech/biopharma sponsor experience, including oversight of CROs in multi-site studies.
• Strong understanding of clinical study data review and data management processes, including Data Monitoring, protocol deviations, and overall data integrity of studies.

Benefits

• Comprehensive medical, dental, and vision coverage
• Company contributions to health savings and retirement accounts
• Ample paid time off
• Access to wellness programs
• Rich career growth opportunities
• Annual incentive bonus as a percentage of actual base salary
• Long-term incentives in the form of employee stock options