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General Manager, Clinical Trials and Site Management

External
ivxhealth logoIvxhealth · Brentwood, TN
Full-timeOn-site4w ago
Clinical TrialsComplianceDocumentationGCPLeadershipStrategic Planning
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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

Health insuranceDental insuranceVision insurance401(k)Remote work optionsFlexible schedulePerformance bonus

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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