Senior Clinical Trial Manager (Contract)

The role

This person will lead the execution of global clinical studies from startup through closeout and clinical study report. They will manage operational strategy, timelines, budget, quality, vendor oversight, risk management, and inspection readiness.

What you will do

• Lead the planning, execution, and oversight of global clinical trials from startup through closeout.
• Serve as the primary operational lead for assigned studies.
• Develop and manage study timelines, budgets, enrollment forecasts, risk mitigation plans, and key performance metrics.
• Oversee CROs and external vendors to ensure delivery against scope, quality standards, timelines, and budget.
• Drive critical study milestones, including site activation, enrollment, database lock, and study closeout.
• Review and approve study plans, vendor deliverables, and trial documentation.
• Identify operational risks and issues and implement mitigation strategies.
• Lead study team meetings and provide regular updates to stakeholders and senior management.
• Ensure Trial Master File (TMF) quality, completeness, and inspection readiness.
• Support regulatory submissions, audits, inspections, and Health Authority interactions.

Required qualifications

• Bachelor's degree in a scientific, health-related, or equivalent discipline
• 8+ years of clinical research experience
• 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 such as: First in Human, Drug to Drug Interaction, Human Absorption, Metabolism, Excretion and Mass Balance, Relative Bioavailability, Bioe
• Demonstrated experience independently leading Phase 1 studies, global Phase II and/or Phase III clinical trials
• Experience managing CROs, CRUs, central vendors, and cross-functional study teams

Nice to have

• Neuroscience/CNS clinical development experience
• Experience supporting inspection readiness, audits, and regulatory interactions

Benefits

• Medical plans, including PPO and EPO options
• Dental coverage
• Vision coverage
• 401 (k)
• Wellness programs
• Other discounts

About the company

Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 (OX2R) agonists for the treatment of narcolepsy and potentially other sleep-wake disorders. It is a wholly owned subsidiary of Eli Lilly and Company.