Clinical Trial Manager

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $132k - $175k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Climb Bio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Climb Bio is a clinical-stage biotechnology company developing differentiated monoclonal antibody therapies to treat immune-mediated diseases. The company is advancing a pipeline that includes programs such as budoprutug (CLYM116) and is exploring CD19-directed opportunities across indications with high unmet need. Climb Bio focuses on diseases like primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, and IgA nephropathy, conducting clinical trials and emphasizing patient-centered development.

📋 Description

• Lead end-to-end delivery of clinical trials, with immediate emphasis on owning Phase 1 execution and supporting Phase 2 execution • Serve as the Clinical Operations representative on study teams • Lead study-level operational execution in partnership with Clinical Development, Regulatory, Data Management, Safety, Statistics, and CMC • Drive alignment and issue resolution • Collaborate with Senior Clinical Trial Managers on complex studies and grow into greater study ownership • Own clinical trial conduct, study-level inspection readiness, TMF health, documentation discipline, investigational product supply, and regulatory submissions support • Conduct proactive study-level risk assessment, prioritization, and escalation • Partner with senior Clinical Operations leadership on study strategy and execution, issue solving, and inspection-ready operational approaches • Support study startup and ongoing management in alignment with GCP, SOPs, and quality standards • Lead study-level operational activities during audits and regulatory inspections, including preparation, inspection support, responses, and CAPAs • Lead CRO and vendor execution, with accountability for quality, timelines, and budget performance • Track clinical expenses and budgets with senior team members • Prepare timely, accurate trial status reports for leadership

🎯 Requirements

• Bachelor’s degree • Minimum of 3 years of experience independently managing clinical trials across Phases 1–3 • 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 • Ability to connect decisions to data integrity and compliance • Ability to influence and mentor others in quality behaviors

🏖️ Benefits

• Discretionary annual bonus • Medical, Dental and Vision benefits • Short-term and long-term disability • Company paid basic life insurance • 401k company match • Generous paid time off • Paid holidays • Stock options • Remote or hybrid work option