Clinical Trial Manager

Summary

Join Caribou Biosciences as a Clinical Trial Manager (CTM) to lead moderately complex clinical trial activities, ensuring compliance with Good Clinical Practice (GCP) and relevant SOP's. The CTM will work closely with the clinical operations team to manage study-essential documents, oversee study milestones, and support financial health. This is a temporary or contract position that requires collaboration with Caribou's internal teams.

Requirements

• Bachelor's degree
• 7 years relevant work experience
• Able to demonstrate proficiency in technology use, documentation practices, business practices, version control management, and document control
• Advanced proficiency in Microsoft 365 suite, including Word, Excel, PowerPoint, Outlook, and SharePoint
• Strong attention to detail and a commitment to producing high-quality work
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Responsibilities

• Support activities related to all phases of clinical studies including: study/site feasibility, start-up, maintenance, and close-out
• Manage and oversee study- and site-essential documents review, collection, and tracking
• Support the initiation, preparation, and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, and pharmacy-, clinical supply- and laboratory-related documents)
• Oversee Study Trial Master File (TMF)
• Ensure required study documents are received, reviewed and filed in the TMF in accordance with GCP and applicable regulations
• Organize and prepare study-related meetings (agenda, minutes, slides, etc.)
• Prepare, oversee and maintain study logs (risk, issue, decision logs, etc.)
• Support and participate in departmental, study team, and service provider meetings
• Attend study related meetings
• Participate in study related collaborative process efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.) Complete monitoring visit report reviews and performs co-monitoring or monitoring oversight visits
• Support, tracks, and triages site and service provider queries
• Support rapid action to address both internal and site QA findings from audits
• Manage, coordinate, and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, and implementation
• Track and maintain studies, including but not limited to study status, enrollment, deviations, documents, and plans
• Support oversight of clinical site performance, metrics, and monitoring visits
• Assist and supports study data related activities including data review, query creation and resolution, study and protocol deviation reviews, and safety reviews
• Work cross-functionally with direction from Clinical Operations
• Review and verifies service provider activities
• Support study reporting and tracking with applicable systems and technology
• Support study lead in cross-functional alignment of study timelines
• Support study lead in financial management of service providers (e.g., contract and invoice reconciliation)

Benefits

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