Senior Clinical Trial Manager
Climb Bio
full-time
Posted on:
Location Type: Hybrid
Location: Wellesley Hills • Massachusetts • United States
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Job Level
Tech Stack
About the role
- Serve as the Clinical Operations representative on project 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
- 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 and asset clinical strategy, 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
Requirements
- Bachelor’s degree
- Proven experience in independently managing clinical trials, with a minimum of 6 years’ experience, spanning Phases 1 – 3 of clinical research
- At least 2 years of experience in a small biotech with demonstrated success independently managing multiple trials & building and scaling processes
- In-depth 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%)
Benefits
- 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
- Paid holiday
- Stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementrisk assessmentregulatory submissionsinspection readinessdocumentation disciplineGCP guidelinesclinical research processesCAPAsbudget managementstudy startup
Soft Skills
communication skillsinterpersonal skillsproblem-solvingjudgement under pressureadaptabilityresilienceleadershipcollaborationissue resolutionrelationship management