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.
Summary of the role: The Clinical Trial Manager (CTM) works on moderately complex clinical trial activities as the lead of a trial and/or in support of the Clinical Operations Project Leadership Directors. The CTM will work closely with the clinical operations team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CTM will assist with service provider oversight and management as well as identify issues promptly and escalate to management as appropriate.
The CTM supports Clinical Operations in ensuring the financial health of assigned clinical studies and overseeing study milestones.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) Other duties as assigned
Qualifications:
- 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
- Ability to engage virtually for a standard working day duration, in the style most comfortable to the employee
- Travel may be required per program or customer needs, but will be discussed and vetted between employee and manager
This position is for a temporary or contract employee who will not be directly employed by Caribou Biosciences. Instead, the individual will be an employee of a third-party staffing firm and their work activities will be managed by the Caribou team. As a temporary/contract employee, you will collaborate closely with Caribou’s internal teams and contribute to our mission while reporting and getting supported by the staffing firm.#Li-REMOTE
