Lead Clinical Study Manager

About the role

For our client, we are seeking a Lead Clinical Study Manager to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the operational planning and execution of clinical studies that support broader clinical strategy across global programs. The individual will partner closely with internal stakeholders, CROs, vendors, and study sites to ensure studies are delivered with quality, efficiency, and regulatory discipline. This is a highly visible position with responsibility for managing budgets, resolving study issues, and keeping programs inspection-ready throughout the study lifecycle.

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

Responsibilities

• Lead operational strategy and planning for clinical studies to support clinical strategy
• Ensure studies are executed in compliance with quality standards and within budget
• Oversee interactions with CROs and other vendors, ensuring alignment with business objectives
• Participate in feasibility and selection processes for study sites and countries
• Provide ongoing support and oversight to address study-related issues promptly
• Manage study budget planning and external spending, ensuring accurate reporting
• Ensure studies are inspection-ready and participate in regulatory inspections

Qualifications

• BS/BA in health-related, life sciences, or technology fields; advanced degree a plus
• 6+ years in the pharmaceutical industry or clinical research, with 4+ years in clinical study management
• Experience in early phase to Phase 3 clinical studies, especially in global programs
• Strong knowledge of global regulatory compliance and ICH GCP requirements
• Exemplary project/program management and leadership skills
• Outstanding communication and interpersonal skills; fluent in business English

Benefits

• Comprehensive health and wellness benefit programs
• Flexible work arrangements and remote work opportunities
• Professional development programs and training
• Mentorship opportunities for career advancement
• Paid travel for work-related assignments

Pay

$116,000 – $182,270 annually