Clinical Trial Manager (CTM)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
