Who we are looking for:

Vor Bio is seeking a Senior Clinical Trial Manager to join our dynamic Clinical Operations team. The Senior Clinical Trial Manager (Sr CTM) is a motivated, independent, organized individual who will be responsible for the successful execution of clinical trials from protocol conception to the Clinical Study Report. The Sr CTM ensures completion of all study deliverables, oversight of the Clinical Research Organization partner(s)/supporting vendors and proactively identifies and resolves clinical trial issues.

Key areas of responsibility:

• Independently lead, manage and coordinate all aspects of the clinical trial, including study timelines, budgets and resources to ensure timely execution and successful completion according to Corporate and Departmental goals
• Contribute to and coordinate the development of the Investigator Brochure, Protocol, Informed Consent Form, operational plans, manuals, training materials, patient-facing materials, Case Report Forms etc. and all required regulatory documents
• Participate in vendor selection, generate applicable Request for Proposals, manage and oversee selected clinical trial vendors
• Build and maintain collaborative, professional relationships with internal cross-functional teams, CROs/vendors, Investigators and clinical site staff
• Manage and monitor trial progress and performance metrics, providing regular updates to cross-functional team and senior management
• Work with Finance to provide accurate accruals and forecasting; contribute to Long Range Planning budget exercise, as needed
• Participate in periodic study data review and oversee site management to ensure data quality and timely data entry
• Manage (oversee) timely data cuts for external data reviews and presentations, publications etc.
• Lead, manage (oversee) and participate in study-related meetings; Study Team Meetings (internal and external), Investigator/Study Coordinator teleconferences, safety review meetings, DSMB and dose escalation meetings etc
• Proactively identify and mitigate risks and issues that may impact trial budget/timelines, implementing appropriate corrective actions as needed
• Oversee the development and maintenance of the Trial Master File (TMF), ensuring regular TMF audits and a final TMF that is complete and inspection-ready
• Contribute to the development of Clinical SOPs, process improvements and work with Quality to support all audit activities
• Manage the trial in accordance with SOPs, GCP/ICH guidelines and all applicable laws and regulations
• Communicate timely updates to ClinicalTrials.gov postings to Regulatory Affairs

Qualifications:

• Bachelor’s degree in health science or a related field
• Minimum 5 years in clinical trial management, with 3 years at a sponsor biotech/pharma
• Experience with Cell and Gene Therapy is highly desirable and 3 years Phase 1-3 experience in Oncology is required
• Thorough working knowledge of current FDA, ICH, GCP regulations and guidelines
• Strong experience facilitating clinical study team meetings, demonstrated by excellent verbal/written communications skills, presentation skills and effective cross-functional communication
• Excellent organizational skills and ability to prioritize activities, manage timelines, and work effectively in a collaborative, fast-paced, cross-functional environment
• Ability and willingness to travel up to 20% (domestic and international)

This is an on-site position at the Vor Bio office in Cambridge, MA