Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the planning, execution, and oversight of global clinical trials from initiation to closeout.

• Act as the primary operational leader for assigned studies.

• Facilitate cross-functional alignment and execution.

• Create and manage study timelines, budgets, enrollment forecasts, risk mitigation strategies, and key performance indicators.

• Supervise CROs and external vendors to ensure adherence to scope, quality standards, timelines, and budget.

• Propel key milestones such as site activation, enrollment, database lock, and study closure.

• Review and approve study plans, vendor deliverables, and trial documentation to ensure compliance with protocol, GCP, and regulatory standards.

• Identify operational risks and challenges, implement mitigation strategies, and escalate issues as necessary.

• Lead study team meetings and provide updates to stakeholders and senior management.

• Ensure the quality, completeness, and inspection readiness of the Trial Master File.

• Assist with regulatory submissions, audits, inspections, and interactions with health authorities.

• Contribute to process enhancements and provide mentorship to junior clinical operations team members.

• Collaborate with global teams, investigators, CROs, and vendors across various regions.

⛳️ Requirements

• A Bachelor's degree in a scientific, health-related, or equivalent discipline is required.

• Over 8 years of clinical research experience, including more than 5 years of clinical trial management experience within a sponsor or CRO setting.

• At least 2 years of experience managing Phase 1 Healthy Volunteer studies.

• Familiarity with 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.

• Proven experience in 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.

• Preferred experience in neuroscience/CNS clinical development.

• Preferred experience in supporting inspection readiness, audits, and regulatory interactions.

• Occasional travel may be 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.