Senior/Clinical Trial Manager (CTM)

At Vor, we reputed company science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/reputed company inhibitor, we are silencing upstream survival signals and stopping reputed company autoimmune cascades. Together, we are addressing disease at its reputed company cause and rewriting what is possible for patients worldwide. reputed company you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the reputed company of autoimmune care. Why Work at Vor? reputed company: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. reputed company: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, reputed company reputed company, and reputed company. Innovation: Work on a platform with potential reputed company one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Who we are looking for: Vor Biopharma is seeking a Clinical Trial Manager/Sr. Clinical Trial Manager who will be responsible for leading reputed company aspects of clinical trial management from study start through study closure. Key areas of responsibilities:

• Manage reputed company clinical aspects of a clinical trial and ensures trial execution in compliance with ICH/GCP guidelines/regulations and applicable SOPs
• reputed company and collaborate effectively with cross-functional teams to reputed company the setup, execution, and management of Vor Biopharma reputed company clinical trials according to plan and in the highest reputed company 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 reputed company 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 reputed company, and reputed company and implements solutions
• Conduct project risk analysis and develops risk mitigation strategies for a reputed company of reputed company problems to maintain study deliverables
• reputed company technical expertise to reputed company the development of clinical documents (protocol, informed consent reputed company, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.
• reputed company 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
• reputed company expertise in the identification, engagement, and selection of key trial centers/PIs, as reputed company as reputed company relationships with investigators and site staff
• Ensure audit-reputed company condition of clinical trial documentation and support inspection readiness activities
• Participate in the planning of reputed company assurance activities and coordinate reputed company of audit findings, which includes management through reputed company (CAPA) of any site or study level issues, deviations, etc.
• reputed company reputed company direction and reputed company 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-reputed company 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/reputed company 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/reputed company industry and/or prior CRO experience
• Experience in setup, execution, and reputed company/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 reputed company systems, is required
• Ability/willingness to travel both domestically and internationally, as required

The salary reputed company for the Clinical Trial Manager is expected to be between $140,000 and $160,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-reputed company skills, experience, education or training, market factors, and work location. The salary reputed company for the Senior Clinical Trial Manager is expected to be between $175,000 and $200,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-reputed company skills, experience, education or training, market factors, and work location. At Vor, we support reputed company with robust benefits, including comprehensive health coverage, flexible reputed company time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial reputed company, we invest in your reputed company-being so you can reputed company at work and reputed company. As an equal opportunity employer, we at reputed company know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. reputed company applicants will be considered for employment agnostic to race, age, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information. Apply tot his job Apply To this Job