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Korro Bio is a biopharmaceutical company developing a new class of genetic medicines using a proprietary RNA editing platform. The company focuses on rare and highly prevalent diseases, leveraging RNA editing to achieve precise, transient single base edits with improved specificity and long-term tolerability.
The Senior Clinical Trial Manager will lead early-phase clinical trials with strong cross-functional collaboration. This role requires planning, driving, and overseeing all aspects of multi-center global clinical trials in compliance with GCP, SOPs, and designated budgets and timelines.
Key responsibilities include:
- Plan and oversee multi-center global clinical trials in compliance with GCP, SOPs, and program budgets/timelines
- Drive implementation of clinical operational strategy for successful study delivery
- Optimize trial design and execution using operational and therapeutic expertise
- Provide oversight and management of CROs and vendors, including contracting and clinical budgets
- Lead study team meetings and coordinate program updates on timelines and milestones
- Contribute to study documentation including protocol review, study plans, ICFs, and CRFs
- Participate in CRO/vendor identification, qualification, and selection
- Oversee site selection, patient accrual tracking, eligibility verification, and adverse event reporting
- Manage clinical monitoring from site qualification through closure; ensure data integrity
- Establish transparent team culture with clear goal-setting and risk-based oversight
- Ensure compliance with internal policies, GCP, and applicable regulations; maintain inspection readiness
- Oversee vendor contracts and clinical study budgets; report progress to finance
- Contribute to Clinical Study Reports and Investigator Brochures
- Manage Trial Master File (TMF) documentation
- Limited travel to field sites (<25%) for supervision and monitoring
Requirements:
- Bachelor's degree in Life Sciences (or related field); advanced degree desirable
- 8+ years of relevant clinical development and operations experience in clinical operations leadership roles
- Demonstrated track record of initiating and delivering early-phase trials, including First-in-Human (FIH) studies
- Experience in rare diseases and early-phase studies highly desirable
- Strong leadership skills driving large cross-functional teams
- Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements, and ICH GCP
- Experience with global regulatory inspections
- Excellent critical and strategic thinking with ability to understand big-picture context and impactful details
- Global clinical operations and development experience across therapeutic areas with demonstrated ability to rapidly learn new indications
- Excellent communicator and influencer; able to persuasively convey ideas and data verbally and in writing
