Senior/Clinical Trial Manager (CTM)

Role Summary

Clinical Trial Manager/Senior Clinical Trial Manager who will be responsible for leading all aspects of clinical trial management from study start through study closure.

Responsibilities

• Manage all clinical aspects of a clinical trial and ensures trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs
• Lead and collaborate effectively with cross-functional teams to oversee the setup, execution, and management of Vor Biopharma complex clinical trials according to plan and in the highest quality standards
• Can multi-task in a fast-paced environment with changing priorities and maintain accurate forecasts, clinical trial budgets, and timelines
• Assist in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget
• Use operational and therapeutic expertise to optimize trial setup, implementation, and execution
• Proactively anticipate/identify study risks and issues, determine escalation pathway, and develop and implements solutions
• Conduct project risk analysis and develops risk mitigation strategies for a variety of complex problems to maintain study deliverables
• Provide technical expertise to oversee the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.)
• Provide clinical operations expertise and strategic leadership in the evaluation, selection, and management of CROs and other external vendors to ensure successful clinical trial implementation and execution of Vor Biopharma clinical trials and ensure that performance expectations are met
• Provide expertise in the identification, engagement, and selection of key trial centers/PIs, as well as develop relationships with investigators and site staff
• Ensure audit-ready condition of clinical trial documentation and support inspection readiness activities
• Participate in the planning of quality assurance activities and coordinate resolution of audit findings, which includes management through resolution (CAPA) of any site or study level issues, deviations, etc.
• Actively provide direction and oversight and foster effective relationships with vendors, investigators, consultants, and colleagues
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Manage and mentor clinical team members, as needed

Qualifications

• BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred
• CTM: Minimum of 5 to 7 years of experience in clinical research with 1-2 years managing trials in the biotech/pharma industry and/or prior CRO experience
• Sr. CTM: Minimum of 7+ years of experience in clinical research with at least 3-5 years managing trials in the biotech/pharma industry and/or prior CRO experience
• Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's or Myasthenia Gravis preferred
• Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail
• Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, proven effectiveness in a fast-moving and growing biotech environment
• Solid working knowledge in Good Clinical Practices and ICH Guidelines and the application to the conduct of clinical trials
• Proficient in MS Office Suite, and understanding Clinical Trial Management System, eTMF, and EDC systems, is required
• Ability/willingness to travel both domestically and internationally, as required

Education

• No additional education details beyond the qualifications listed