Clinical Operations Assistant Jobs in Massachusetts

Who we are looking for:

Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune programs. The ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The successful candidate will report to the Vice President, Clinical Operations. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects.

Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an understanding of clinical drug development and clinical trials operations are essential.

Key areas of responsibilities:

• Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs
• Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan
• Support the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate
• Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Assist in forecasting clinical trial material and ancillary supplies
• Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures
• Ensure timely review of protocol deviations and assess the impact on study data
• Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study status, cost, and issues to ensure timely decision-making by senior management
• Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma
• Support program level deliverables/activities at the discretion of the Head of Clinical Operations
• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise
• Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs and ensure all appropriate documents are filed
• Participate and respond to Quality Assurance and/or regulatory authority inspection audits
• Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders
• Manage the clinical trial budget and provide financial reporting and projections to Finance
• Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary

Qualifications:

• BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred
• Minimum of 8 years of experience in clinical research with at least 5 years of 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 and/or Myasthenia Gravis experience preferred
• Experience working on late-stage studies (Phase II, III)
• 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, and proven effectiveness in a fast-moving and growing biotech environment
• Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials
• Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required
• Ability/willingness to travel as required
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

The salary range for this position is expected to be between $195,000 and $220,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.