Senior Clinical Trial Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $127k - $1.8M / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead planning, execution, and oversight of global clinical trials from startup through closeout • Serve as primary operational lead for assigned studies • Drive cross-functional alignment and execution • Develop and manage study timelines, budgets, enrollment forecasts, risk mitigation plans, and key performance metrics • Oversee CROs and external vendors against scope, quality standards, timelines, and budget • Drive milestones including site activation, enrollment, database lock, and study closeout • Review and approve study plans, vendor deliverables, and trial documentation for protocol, GCP, and regulatory compliance • Identify operational risks and issues, implement mitigation strategies, and escalate as appropriate • Lead study team meetings and provide updates to stakeholders and senior management • Ensure Trial Master File quality, completeness, and inspection readiness • Support regulatory submissions, audits, inspections, and Health Authority interactions • Contribute to process improvements and mentor junior clinical operations team members • Collaborate with global teams, investigators, CROs, and vendors across multiple regions

🎯 Requirements

• Bachelor's degree in a scientific, health-related, or equivalent discipline required • 8+ years of clinical research experience, including 5+ years of clinical trial management experience within a sponsor or CRO environment • 2+ years of managing Phase 1 Healthy Volunteer studies • Experience in standard clinical pharmacology package studies, including First in Human, Drug to Drug Interaction, Human Absorption, Metabolism, Excretion and Mass Balance, Relative Bioavailability, Bioequivalence, Organ Impairment, and Abuse Liability studies • Demonstrated experience independently leading Phase 1 studies and global Phase II and/or Phase III clinical trials • Experience managing CROs, CRUs, central vendors, and cross-functional study teams • Neuroscience/CNS clinical development experience preferred • Experience supporting inspection readiness, audits, and regulatory interactions preferred • Occasional travel required

🏖️ Benefits

• Discretionary annual bonus • 401(k) plan • Company-sponsored medical, dental, vision and life insurance • Generous paid time off • Health and wellness program • Pension • Vacation benefits • Prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities