Senior Clinical Trial Manager

Climb Bio

Senior Clinical Trial Manager at Climb Bio leading end-to-end execution of Phase 1-3 clinical studies. Critical role in clinical operations and study management with a focus on quality and compliance.

Posted 4/14/2026full-timeWellesley Hills • Massachusetts • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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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