Clinical Trial Manager

Summary

Join Caribou Biosciences as a Clinical Trial Manager (CTM) and play a pivotal role in executing and overseeing clinical trials from initiation to completion. Ensure adherence to ICH-GCP guidelines, regulations, and internal SOPs. Collaborate effectively with cross-functional teams, manage vendors and sites, and contribute to high-quality clinical trial delivery. Report to the Director of Clinical Operations. This position offers flexibility with on-site, hybrid, or remote work options. Responsibilities include study planning and start-up, execution and oversight, compliance, risk management and communication, and cross-functional collaboration. The ideal candidate will possess a strong background in clinical operations and a proven track record of success in managing clinical trials.

Requirements

• BS in Life Sciences or related field with 6+ years clinical operations experience (or MS with 4+ years)
• Prior sponsor-side clinical trial management experience
• Demonstrated proficiency in clinical trial oversight, including CRO and vendor management
• Strong command of ICH-GCP and regulatory requirements
• Advanced skills in Microsoft Office Suite and clinical systems (e.g., CTMS, eTMF)
• Excellent organizational, problem-solving, and interpersonal communication skills

Responsibilities

• Support feasibility assessments, site selection, and study start-up activities
• Contribute to the development and review of protocols, ICFs, and trial-related documentation
• Lead creation and maintenance of study trackers, timelines, and study-specific tools
• Coordinate vendor and site qualification, selection, and onboarding
• Oversee site activation, patient enrollment, and trial execution activities
• Monitor trial progress and site/vendor performance against timelines and deliverables
• Review and approve site-specific documents including budgets and monitoring reports
• Conduct regular data reviews and support query resolution and deviation tracking
• Manage inventory and logistics for study supplies and investigational products
• Maintain an inspection-ready Trial Master File (TMF)
• Identify and mitigate risks through proactive trial-level risk assessments
• Ensure adherence to ICH/GCP, regulatory requirements, and internal SOPs
• Participate in audits and inspections, including site, vendor, and internal QA reviews
• Develop and deliver training to investigators, sites, and internal teams
• Provide timely updates to stakeholders on study status, risks, and mitigation strategies
• Partner closely with internal stakeholders to align on trial design and execution
• Support Clinical Data Management, Medical Monitoring, and Regulatory teams as needed
• Collaborate with Finance to manage trial budgets and forecasting

Preferred Qualifications

• Experience with CAR-T or oncology trials
• Familiarity with clinical trial execution in a start-up or fast-paced environment
• Current or recent CTM title for at least 1 year

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $150,000 to $165,000 - This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program