At Climb Bio, our team has a knack for seeing what no one else sees-and a drive to achieve results no one expects. We are seeking a self-motivated Clinical Trial Manager to lead end-to-end delivery of clinical trials, with immediate emphasis on owning Phase 1 execution and supporting Phase 2 execution. Reporting to the Director of Clinical Operations, this person will play a critical role in enabling Climb to deliver on its mission.
Key Responsibilities:
- Serve as the Clinical Operations representative on study teams, leading study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC, and proactively driving alignment and issue resolution
- Support and collaborate closely with Senior Clinical Trial Managers on complex studies, operating in a support capacity while demonstrating eagerness to learn and grow into greater study ownership over time
- Accountable for end-to-end trial ownership, including clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply and regulatory submissions support, with responsibility for proactive study-level risk assessment, prioritization, and escalation
- Operate effectively in a fast-moving biotech environment, demonstrating resilience, sound judgement under pressure, and the ability to adapt execution approaches while maintaining quality and compliance amid shifting priorities
- Partner with senior Clinical Operations leadership on study strategy and execution, issue solving, and development of high-quality, inspection-ready operational approaches
Additional Responsibilities:
- Support study startup and ongoing management in alignment with GCP, SOPs, and quality standards
- Serve as the study-level operational lead during audits and regulatory inspections, including preparation, inspection support, and execution of responses and CAPAs
- Lead CRO and vendor execution with clear accountability for quality, timeline, and budget performance, exercising judgement to resolve issues, recommend trade-offs, and escalate risks as appropriate
- Support senior team members in tracking clinical expenses and budgets
- Prepare timely, accurate trial status reports for leadership
Qualifications:
- Bachelor's degree
- Minimum of 3 years of experience independently managing clinical trials across Phases 1 - 3, including at least 2 years in a biotech managing studies through start-up and maintenance stages
- Working knowledge of clinical research processes, GCP guidelines, and regulatory requirements
- Excellent communication and interpersonal skills with a focus on managing external relationships effectively
- Proficiency in MS Suite
- Ability to travel occasionally (approximately 20%)
Key Competencies:
- Strategic planning and organizational skills
- Analytical and problem-solving abilities
- Ability to work effectively with external partners in a dynamic, fast-paced environment
- Attention to detail and commitment to quality, with ability to connect decisions to data integrity and compliance, and to influence and mentor others in quality behaviors
This role has the option of being remote or hybrid based out of our office in Wellesley, MA.
Base salary offered may vary depending on individual's skills, experience, and competitive market value.
Salary Range: $132,000-$175,000
Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.
