Clinical Trial Manager

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🔥 10 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $160k - $175k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Caribou Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 $125M Post-IPO Equity on 2023-07

Healthcare • Consulting • Biotechnology

Caribou Biosciences is a clinical-stage biopharmaceutical company focused on developing transformative genome-edited allogeneic cell therapies for treating devastating human diseases. Utilizing next-generation CRISPR genome-editing technologies, including their proprietary chRDNA (CRISPR hybrid RNA-DNA) technology, Caribou is at the forefront of precision genome editing. Their technologies allow for complex genome editing with superior specificity and precision, such as multiplex gene knockout and insertion while maintaining genomic integrity. Caribou is pioneering off-the-shelf CAR-T cell therapies from healthy donor cells to address limitations of current therapies. They use their cutting-edge technologies to enhance the effectiveness of cell therapies through strategies like checkpoint disruption and immune cloaking. Co-founded by Jennifer Doudna, a Nobel Prize recipient, Caribou Biosciences is recognized as a leader in the CRISPR field.

📋 Description

• Manage operational activities across all phases of clinical studies, including feasibility, start-up, maintenance, and close-out • Support study planning and execution, including site and vendor identification, evaluation, qualification, and oversight • Implement operational strategies supporting patient enrollment, site monitoring, and trial execution • Manage clinical trial operations from study start-up through Clinical Study Report completion • Develop and manage study tools, documentation, timelines, trackers, communications, and key study documents • Identify, assess, track, mitigate, and document trial-level operational risks • Organize study meetings, agendas, minutes, presentations, and action items • Provide Sponsor oversight of CRO and vendor performance, deliverables, metrics, and governance • Coordinate investigational product, laboratory, sample management, and study supply logistics • Perform ongoing Sponsor data review, query management, protocol deviation review, safety review, and issue resolution • Review monitoring reports and participate in monitoring or oversight visits as appropriate • Maintain the Trial Master File and inspection readiness • Review or approve site-specific documents, including informed consent forms, site budgets, and monitoring reports • Support audits, inspections, investigator and site training, process improvements, and strategic initiatives • Provide trial updates, operational risks, and mitigation strategies to stakeholders • Collaborate with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Monitoring, Drug Supply, Quality Assurance, Safety, and other cross-functional partners

🎯 Requirements

• BS degree in the life sciences with a minimum of 6+ years in Clinical Operations, or 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, including Word, Excel, PowerPoint, Outlook, and SharePoint • Strong attention to detail and commitment to high-quality work • Excellent written and verbal communication and interpersonal skills • Ability to travel up to 20% based on business needs • Legal authorization to work in the United States

🏖️ Benefits

• Comprehensive compensation package including competitive salary, bonus, and equity • Salary range of $160,000–$175,000 • Generous paid vacation time • Company-observed holidays • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement savings plan with matching employer contributions • Employee stock purchase plan (ESPP) • Tuition reimbursement program