Note: The job is a remote job and is open to candidates in USA. Helios Clinical Research is a company dedicated to advancing oncology research while delivering exceptional patient care. The Vice President of Clinical Operations – Oncology will provide strategic leadership and operational oversight across oncology research sites, ensuring compliance and driving performance while partnering with various stakeholders.
Responsibilities
- Provide strategic leadership and direction for all oncology clinical operations
- Develop and execute operational strategies aligned with organizational goals
- Foster a culture centered on patient safety, quality, accountability, and continuous improvement
- Serve as a trusted advisor to executive leadership regarding clinical operations and site performance
- Lead organizational initiatives, change management efforts, and operational integrations
- Oversee the day-to-day operations of multiple oncology research clinics
- Ensure consistent execution of clinical research protocols while maintaining exceptional patient care
- Establish operational standards and best practices across all Oncology sites
- Monitor operational metrics including patient enrollment, study activation timelines, visit completion, protocol compliance, site productivity, and financial performance
- Develop corrective action plans when operational goals are not achieved
- Drive continuous improvement initiatives to increase efficiency and study performance
- Partner closely with Principal Investigators and Sub-Investigators to ensure successful study execution
- Build strong relationships with physician leadership and clinic management
- Support physician engagement in new study opportunities
- Resolve operational issues impacting patient care or study execution
- Promote collaboration across physicians, coordinators, regulatory, pharmacy, laboratory, and business departments
- Ensure compliance with FDA regulations, ICH-GCP Guidelines, Oncology requirements, sponsor requirements, IRB requirements, and company SOPs
- Collaborate closely with Regulatory Affairs and Quality Assurance
- Support FDA inspections, sponsor audits, and internal quality reviews
- Implement corrective and preventive actions (CAPAs)
- Promote a culture of quality and regulatory excellence
- Develop and manage operational budgets
- Monitor clinic profitability and financial performance
- Partner with Finance regarding revenue forecasting, staffing models, and operational efficiencies
- Support business development efforts and evaluate operational feasibility of new opportunities
- Assist in site expansion, acquisitions, and integration initiatives
- Lead, mentor, and develop Directors, Site Operations Managers, Clinical Managers, and operational leaders
- Establish performance expectations and accountability measures
- Conduct performance evaluations and coaching
- Support succession planning, recruitment, retention, and employee development
- Partner with Executive Leadership, Medical Directors, Principal Investigators, Regulatory Affairs, Quality Assurance, Human Resources, Finance, Business Development, Information Technology, Sponsors, and CROs to ensure operational excellence
- Evaluate operational readiness for new oncology studies
- Support expansion into new therapeutic areas
- Assist with mergers, acquisitions, and integration of new research sites
- Identify innovative technologies and operational improvements
- Develop long-term strategic plans to increase operational efficiency and market growth
Skills
- Bachelor's degree in Nursing, Healthcare Administration, Life Sciences, or related field required
- Minimum 10 years of progressive clinical research leadership experience
- Minimum 5 years leading multi-site oncology clinical operations
- Experience working directly with Principal Investigators and oncology physicians
- Experience with FDA inspections and sponsor audits
- Extensive knowledge of FDA regulations, ICH-GCP, oncology clinical trials, and clinical research operations
- Strong business and financial acumen
- Excellent leadership, communication, organizational, and project management skills
- Ability to analyze operational metrics and implement strategic improvements
- Ability to build strong relationships with physicians, sponsors, and executive leadership
- Master's degree (MBA, MHA, MSN, MPH, or similar) strongly preferred
- Executive leadership experience preferred
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