We are seeking a
Clinical Trial Manager (CTM) to join our Clinical Operations group. You will be responsible for the operational execution and Sponsor oversight of global clinical trial activities from study start-up through study close-out. The CTM ensures trials are conducted in accordance with ICH-GCP, applicable country regulations, standard operating procedures, and study-specific protocols.
The CTM will report to the Director of Clinical Operations. This position may be onsite, hybrid, or remote.
Responsibilities:Study Management- Manage operational activities related to all phases of clinical studies, including study/site feasibility, start-up, maintenance, and close-out
- Support study operational planning and execution, including site and vendor identification, evaluation, qualification, and oversight
- Implement operational strategies to support timely patient enrollment and maintain high standards for site monitoring and trial execution
- Manage operational aspects of clinical trials throughout the study lifecycle from study start-up through to Clinical Study Report completion
- Develop and manage study-specific operational tools, documentation, timelines, trackers, and communications, while coordinating cross-functional development and review of key study documents
- Manage trial-level operational risks, including identification, assessment, tracking, mitigation, and documentation to ensure compliance, and quality across trial activities
- Organize and prepare for study-related meetings, including agendas, minutes, presentations, and action items
CRO and Vendor Oversight- Provide Sponsor oversight of CRO performance related to site qualification, site initiation, monitoring, enrollment, data quality, sample logistics, and site close-out activities
- Review vendor performance, deliverables, key performance metrics, and governance activities to ensure contractual obligations and study expectations are met
- Collaborate with Supply Chain, CROs, and external vendors to support investigational product, laboratory, sample management, and study supply logistics
- Review and verify service provider deliverables and operational activities for quality and timeliness
Data Review and Quality Oversight- Perform ongoing Sponsor data review to identify trends and support query management, protocol deviation review, safety review, and issue resolution
- Review monitoring visit reports and, as appropriate, participate in co-monitoring, monitoring, or oversight visits.
- Support oversight of clinical site performance through review of study metrics, monitoring data, and trends
- Ensure all trial operations are executed within timelines and budgets while adhering to ICH-GCP, applicable regulations, and company procedures
Trial Master File and Inspection Readiness- Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness
- Review and/or approve site-specific documents, including informed consent forms, site budgets, monitoring reports, and other study documentation
- Support the preparation, conduct, and follow-up of audits and inspections, including site, vendor, and internal quality audits
Cross-Functional Collaboration- Provide timely updates on trial progress, operational risks, and mitigation strategies to stakeholders
- Support the development and implementation of study training for investigators, site staff, and internal teams
- Collaborate effectively with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Monitoring, Drug Supply, Quality Assurance, Safety, and other cross-functional partners to ensure successful trial execution
- Support Clinical Operations process improvements, infrastructure development, and other strategic initiatives as assigned
Requirements:- BS degree in the life sciences with a minimum of 6+ years in Clinical Operations, with a MS degree in the life sciences with a minimum of 4+ years of Clinical Operations experience
- 3 years of Sponsor Clinical Trial Management experience
- Experience supporting complex global Phase III clinical trials
- Cell therapy or Oncology Experience
- Strong understanding of ICH-GCP, FDA, EMA, and applicable global regulatory requirements
- Demonstrated proficiency in technology use, documentation practices, and sound business acumen
- Advanced proficiency in Microsoft 365 (Word, Excel, PowerPoint, Outlook, and SharePoint)
- Strong attention to detail and a commitment to producing high-quality work
- Excellent written and verbal communication and interpersonal skills
- Ability to travel up to 20% based on business needs
Nice-to-haves:- Experience working in a fast-paced, dynamic start-up biotechnology environment
Caribou compensation and benefits include:- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $160,000 - $175,000; 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
- Excellent medical, dental, and vision insurance
- 401(k) retirement savings plan, which includes matching employer contributions
- Employee stock purchase plan (ESPP)
- Tuition reimbursement program
The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
