Job Title: Senior Manager, Clinical Trial Management

Work Location: Tri-State Area (East Coast)

Summary:

The Senior Manager, Clinical Trial Management is responsible for leading the operational strategy and execution of complex global clinical studies, ensuring compliance with clinical plans, SOPs, ICH/GCP, and local regulations. This role requires hands-on trial management, cross-functional collaboration, and a focus on quality, inspection readiness, and process improvement. Experience in gene therapy or CAR-T is required.

Responsibilities:

• Oversee daily operations of assigned clinical studies, ensuring alignment with program goals, timelines, budgets, and quality standards.
• Lead cross-functional teams to drive effective study execution, collaborating with various departments to ensure seamless operations.
• Manage study budgets, including forecasting, tracking, and reconciliation, while coordinating with external partners and finance teams.
• Provide oversight of vendors, ensuring adherence to scope, budget, and performance expectations, and resolving issues as needed.
• Maintain comprehensive documentation to demonstrate sponsor oversight and ensure inspection readiness at all times.
• Contribute to operational planning, including risk-based monitoring, patient recruitment and retention, and risk mitigation strategies.
• Support protocol development and database design by providing operational input on patient/site burden, diversity, and risk assessments.
• Participate in departmental initiatives and process improvements, supporting study start-up, vendor selection, and regulatory submissions.

Qualifications:

• BA/BS degree with at least 7 years of clinical trial management experience, or advanced degree (MS/PhD, PharmD) with at least 4 years of study management experience; life sciences or equivalent preferred.
• Strong knowledge of ICH/GCP and regulatory requirements; prior site monitoring and CRA experience required.
• Experience with gene therapy, GMO, and IBC submissions required.
• Demonstrated skills in clinical study management, including timeline and budget development, vendor/CRO oversight, drug supply, and site management; global experience preferred.
• Experience with sites or vendors in Brazil/South America is a plus.
• Proven ability to manage complex protocols, budgets, timelines, and vendor relationships.
• Excellent written and verbal communication skills, with the ability to provide clear direction to stakeholders.
• Analytical and problem-solving skills, attention to detail, and a collaborative work style.
• Willingness to travel domestically and internationally as required, including quarterly travel to New York County.

Published Category: Clinical Operations & Development