Note: The job is a remote job and is open to candidates in USA. Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Clinical Trial Manager will lead end-to-end delivery of clinical trials, with an immediate focus on Phase 1 execution and support for Phase 2 studies, while coordinating cross-functional teams, CROs, vendors, and trial operations.
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
- 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
Skills
- 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%)
- 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
Benefits
- The role has the option of being remote or hybrid based out of our office in Wellesley, MA.
- Discretionary annual bonus
- 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
- Stock options
Company Overview