Lead Clinical Study Manager (Lead CSM)

This role will support clinical priorities focused on quality, patient-centered outcomes, and effective care delivery. You will collaborate with clinical leaders, operational teams, and cross-functional stakeholders to improve standards, workflows, and execution. The position offers the opportunity to strengthen care quality, team performance, and measurable outcomes within a life sciences environment.

Responsibilities

• Lead planning and execution of operational strategy for assigned clinical trials
• Provide expertise for developing protocol synopsis and related study documents
• Challenge study feasibility and ensure budget impacts are addressed
• Participate in site feasibility/selection processes and provide therapeutic expertise
• Oversee and support Strategic Partners/CROs to swiftly resolve study issues
• Manage budgets, communicate study status, and serve as escalation for third-party vendor issues
• Ensure studies maintain 'inspection-ready' status and prepare for regulatory inspections

Qualifications

• BS/BA in health-related, life science, or technology-related fields required; advanced degrees are a plus
• 6+ years' experience in the pharmaceutical industry/clinical research, focusing on clinical study management/oversight
• Experience with early phase clinical studies or global Phase 2 and 3 studies required
• Knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP
• Demonstrated excellence in project/program management, matrix leadership, and communication skills

Benefits

• Eligible for medical, dental, and vision insurance
• 401(k) plan with company match and disability coverage
• Tuition reimbursement and paid volunteer time off
• Up to 120 hours of paid vacation and 80 hours of sick time
• Hybrid work environment classified as 'remote'

Pay

$116,000 – $182,270 annually

Location: Remote - US based candidates only, no visa sponsorship available