[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.
Apply Now
Apply Now
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.
Apply Now
Apply Now