General Manager, Clinical Trials and Site Management
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About the role
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.
Responsibilities
- 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.
- What You Bring
- Required
- 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.
- Preferred
- 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.
- About IVX Health
- Our Mission: To improve the lives of those we care for by redefining the care experience
- Our Vision: To be the nation's preferred destination for pharmaceutical care of complex chronic conditions
- Our Commitment: To deliver an unmatched care experience with a foundation in world class service and clinical excellence
- Benefits We Offer
- 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.
- Note: Benefits may vary by employment type. Contact HR for details on eligibility and coverage.
- EEO STATEMENT
- IVX Health is proud to be an Equal Opportunity Employer. We value diversity an
Benefits
Additional Information
Location: Brentwood, TN. (Onsite Preferred; Remote Considered) IVX Health is a national leader in high‑quality infusion and injection therapy, operating 150+ ambulatory centers across the U.S. Backed by Linden Capital Partners, we continue to scale rapidly-expanding services, accelerating growth, and building the leading ambulatory infusion platform in the country. We are launching a clinical trials platform across our national footprint and seeking a senior operator to build, lead, and scale this new business.
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