- Executes the day-to-day operations of clinical trials from the protocol concept through the clinical study report, per established goals and objectives in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements as applicable.
- Develops and manages comprehensive trial timelines and metrics.
- Ensure that clinical trials are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
- Develop and manage trial budget(s) and maintain within financial goals.
- Drive selection, management and oversight of external vendors including planning, executing trial-specific meetings, key performance indicators and participates, as applicable, in vendor management governance.
- Lead the identification and management of third-party Clinical Operations vendors, including development of Request for Proposals (RFPs), scope of work (SOW) documents, and vendor specifications.
- Perform and document trial level Sponsor Oversight of outsourced clinical activities.
- Manage invoice and budget tracking for individual trials and provide input into monthly and bi-annual accrual/forecasting activities for trials and programs.
- Review and provide functional input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans, as appropriate.
- Prioritize day-to-day issues and Corporate/Clinical goals, escalating issues to Senior Management as appropriate.
- Provide real time updates to Senior Management and cross-functional teams to ensure seamless communication and collaborative working relationships.
- Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
- Coordinate activities related to audit findings and/or identification of significant site noncompliance.
- Develop relationships with Key Opinion Leaders.
- Coach and provide guidance to Clinical Operations team; may have management responsibilities for Clinical Operations team members.
- Manage direct reports, conduct regular meetings and oversight as well as complete all annual performance review activities, as applicable.
- Train and mentor junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities.
- Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance.
- Strive for continuous improvement and more efficient ways of working within the Clinical team.
- May serve as subject matter expert (SME) in one or more areas such as development of SOPs, systems, tools, best in class standards for operational execution etc.
- Minimum of BA/BS with a minimum of 8 years of clinical trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure).
- Experience with Cell and Gene Therapy is highly desirable and 4+ years Phase 1-3 experience in Oncology is required.
- Robust experience in early and late phase global drug development.
- Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Cross-collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
- Advanced working knowledge of current FDA, ICH, GCP regulations and guidelines
- Experience in GCP inspections/audits.
- Outstanding verbal and written communication skills, in addition to excellent organizational skills.
- Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry.
- Resilient, creative, capable problem-solver.
- Excellent organizational skills and ability to work independently.
- Experience in establishing and maintaining relationships with key opinion leaders.
- Ability and willingness to travel up to 20%.
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Director, Clinical Operations - Cambridge, United States - Vor Biopharma Inc.
Description
Who we are looking for:
Vor Bio is seeking a highly motivated Director, Clinical Operations to join our fast-paced, dynamic team at this exciting phase of our Clinical Development Program.
Key areas of responsibility:
Qualifications:
