[Hiring] General Manager, Clinical Trials and Site Management @IVX Health
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Role Description
- The General Manager, Clinical Trials & Site Management will design and run IVX Health’s clinical trials operating model - from start-up through national expansion. This leader will ensure compliant, inspection‑ready performance across all sites, serve as the external-facing executive for sponsors and CROs, and ultimately own the P&L for the clinical trials service line.
- Build and operationalize a scalable clinical trial site management model leveraging IVX Health’s clinical and operational infrastructure.
- Lead execution of clinical trials across multiple sites, ensuring protocol adherence, predictable study start‑up, and high‑quality administration and documentation.
- Serve as the senior accountable leader for regulatory compliance, quality, SOP governance, training, documentation integrity, and CAPA.
- Partner with Clinical, Operations, Legal, Finance, and Regional teams to integrate research into daily clinical workflows.
- Represent IVX Health as an operational subject matter expert in sponsor and CRO discussions, supporting feasibility, execution, and compliance credibility.
- Build and lead a centralized trials team to support scale and standardization.
- Assume increasing financial accountability, evolving to full P&L ownership and long‑term strategic planning.
- Qualifications
- 10+ years of senior experience in clinical trial site management, SMO leadership, or research operations within an academic medical center.
- Direct, hands-on leadership of clinical trial sites and active studies from start‑up through close‑out.
- Deep expertise in FDA regulations, ICH GCP, IRB requirements, inspections, audits, and CAPA management.
- Proven ability to lead cross‑functional teams and serve as a credible executive with sponsors and CROs.
- Requirements
- Experience executing or scaling multi‑site clinical trials.
- Exposure to P&L ownership or financial accountability (formal GM title not required).
- Background in infusion-based or procedure-intensive trials.
- Experience scaling operations while maintaining high regulatory and quality standards.
- Benefits
- Comprehensive Healthcare – Medical, dental, and vision coverage, including prescription drug plans and telemedicine services.
- Flexible Savings Options – Choose from Health Savings Accounts (HSA) and Health Reimbursement Arrangements (HRA) to manage healthcare costs.
- Supplemental Protection – Accident, critical illness, and hospital indemnity plans to provide additional financial security.
- Dependent Care FSA – Pre-tax savings for eligible childcare and dependent care expenses.
- 401(k) Retirement Plan – Secure your future with a competitive company match.
- Disability Coverage – Voluntary short-term and long-term disability plans to protect your income.
- Fertility and Family Support – Resources and benefits designed to support fertility care and family planning.
- Life and AD&D Insurance – Financial protection for you and your loved ones.
- Counseling and Wellness Support – Free resources to support emotional, physical, and financial well-being.
- Education Assistance – Tuition reimbursement and certification support to help you grow in your career.
- Continuing Education – Access to a CEU library for ongoing professional development.
- Charitable Giving and Volunteer Program – Matched donations and paid volunteer time off to support causes you care about.
- Employee Referral Bonus – Earn rewards for helping us find top talent.
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