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Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this role, you will serve as the operational lead - driving timelines, fostering collaboration, and ensuring the successful execution of clinical trials. The CTM will oversee day-to-day activities throughout the clinical trial lifecycle.
Job Responsibility:
Manage all project team activities related study start up, conduct and close out activities
Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget
Manage Change Orders with Sites (and Vendors when necessary)
Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF
Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities
Contribute to (or oversee the management of) the creation of the trial plans and site facing documents
Develop (or overseeing the development of) all training/day to day materials
Support data management activities
Monitor (and escalate appropriately) vendor metrics and vendor performance
Organize, oversee and/or participate in all study related meetings
Develop and maintain (or oversee) the development of the Trial Master File
Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc.
Requirements:
Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials
Phase I experience is strongly preferred
a background in rare disease and/or metabolic disorders is highly desirable
experience with cell & gene therapy is a plus
Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes
Exceptional organizational skills and ability to deal with competing priorities
strong reasoning and problem solving ability
Ability and willingness to travel up to 20% (domestic and international)
Nice to have:
Phase I experience
a background in rare disease and/or metabolic disorders
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