At LogicBio, our mission is to develop medicines to durably treat rare diseases in patients with significant unmet medical needs using, GeneRide™, our proprietary technology platform. GeneRide™ enables the site-specific integration of a therapeutic transgene in a nuclease-free and promoterless approach by relying on the native process of homologous recombination to drive lifelong expression. Headquartered in Cambridge, Mass., we are committed to developing medicines that will transform the lives of pediatric patients and their families.
LogicBio is seeking a Clinical Trial Manager to manage one or more clinical trials, including trial start-up, conduct, and close-out activities.
This is a unique opportunity to join an innovative entrepreneurial biotech and contribute to development of a novel gene therapy/genome editing technology for treating pediatric patients with high unmet medical need.
- Act as clinical operations lead for LogicBio clinical studies. Responsible for all aspects of clinical trial execution including budget, vendor oversight, operational planning and risk management.
- Oversee CRO and central lab vendors ensuring quality and timely execution. Prepare or review study plans including key milestones; maintain timelines and provide regular study status updates to internal team. Work with CRO on site identification and selection. Develop and execute quality oversight plan.
- Assist in development of clinical trial budgets, including participating in negotiation of vendor scope of work, site budgets, and ongoing oversight/coordination with finance team.
- Prepare or review site level documentation, including informed consent forms, study budgets and clinical trial agreements in coordination with legal.
- Ensure trial adherence to ICH/GCP/local regulations, country and site selection meet study requirements. Ensure availability of clinical/non-clinical supplies, and internal and external systems are updated in a timely manner (CTMS, clinicaltrials.gov).
- Participate in development and user acceptance testing of clinical systems (laboratory, EDC, IVRS, etc.).
- Build relationships and communicate effectively with internal and external study personnel (investigative staff, vendors, etc.), including identifying and addressing any quality and compliance concerns.
- Provide input for clinical regulatory documents (IB, CSR, DSUR)
- Sponsor oversight of the Trial Master File, ensuring audit-ready state.
- Author/co-author protocols in collaboration with Medical Monitor and other stakeholders.
• Bachelor's Degree required.
• Experience in gene therapy not required but preferred.
• 5+ years' experience managing clinical trials within biotech, pharmaceutical or medical device environment.
Experience & Skills
• Excellent verbal and written communication skills.
• Experience in a start-up environment preferred.
• Must be pro-active team player, flexible, and open to change.
• Knowledge of GCP and ICH.
• Experience developing study plans and budgets including risk mitigation strategies.
• Experience in early phases of research preferred.
• Ability to travel as needed to vendors and sites (up to 30%)