Trial Master File Manager Jobs (NOW HIRING)

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

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: $145,000 - $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
• 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.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

• We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.