Clinical Study Associate Manager (CSAM) -Armonk, NY, Cambridge MA or Warren, NJ

Position Summary

Clinical Study Associate Managers (CSAM)

Key Responsibilities

• Lead or support the planning and management of clinical studies in assigned regions, aligned with global study strategy
• Drive risk identification and mitigation, feasibility assessments, and country/region selection
• Oversee the development and quality of key study documents (CRFs, monitoring plans, data management plans, etc.)
• Manage study systems including CTMS and TMF, ensuring accuracy and inspection readiness
• Cook up and coordinate investigator meetings, vendor oversight, study drug forecasting, and supply management
• Develop and implement effective recruitment and retention strategies
• Maintain study progress, data quality, and timeline/budget performance, escalating issues as needed
• Support audit and inspection readiness throughout the study lifecycle
• Lead study close-out activities, including database lock, TMF reconciliation, and vendor finalization

Requirements

• Bachelor’s degree with a minimum of 4 years of relevant clinical research experience
• Strong working knowledge of ICH-GCP and applicable regulatory guidelines
• Proficiency with CTMS, EDC, IWRS/IVRS, and Microsoft Office applications (Teams, Project, etc.)
• Demonstrated ability to lead and influence cross-functional teams and external partners
• Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities
• Proactive, deadline-driven, and comfortable working both independently and collaboratively
• Strong communication, presentation, and stakeholder management skills