Senior Clinical Trial Manager

Eli Lilly and Company

. Lead planning, execution, and oversight of global clinical trials from startup through closeout .

Posted 10/15/2026full-timeRemote • United StatesSenior💰 $127,000 - $1,800,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global clinical trials, including planning, execution, and oversight, while ensuring compliance with regulatory standards. Proficient in managing study timelines, budgets, and cross-functional teams to drive successful trial outcomes.

Highest-signal resume keywords

Clinical Trial ManagementCRO ManagementRegulatory CompliancePhase 1 Study LeadershipRisk Mitigation Strategies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchStudy Timeline ManagementBudget ManagementEnrollment ForecastingGCP ComplianceTrial Master File ManagementPhase 1 StudiesPhase II Clinical TrialsPhase III Clinical TrialsOperational Risk Identification

Soft Skills

Cross-Functional CollaborationStakeholder CommunicationTeam LeadershipMentoring

Industry Keywords

Clinical PharmacologyFirst in Human StudiesDrug to Drug Interaction StudiesHuman Absorption StudiesMass Balance StudiesRelative Bioavailability StudiesBioequivalence StudiesOrgan Impairment StudiesAbuse Liability StudiesNeuroscience Clinical Development

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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