Senior Clinical Research Manager

Responsibilities

• Oversee the operational management of complex cell and gene therapy clinical research studies.
• Lead the coordination and execution of investigator-initiated and industry-sponsored clinical trials.
• Supervise, mentor, and conduct performance appraisals for Clinical Research Coordinators.
• Ensure strict compliance with GCP, HIPAA, IRB, FDA regulations, and FACT guidelines.
• Coordinate cross-functional collaboration between clinical teams, research pharmacy, and laboratories.
• Manage study workflows, participant recruitment, enrollment, and regulatory documentation.
• Track study budgets, participant payments, and financial performance in collaboration with finance teams.
• Maintain accurate research documentation and support monitoring visits and audits.

Requirements

• Bachelor’s degree in health sciences, life sciences, public health, nursing, or a related field.
• Minimum 4 years of clinical research experience, preferably in an academic medical center.
• Demonstrated experience coordinating complex clinical trials from start-up through close-out.
• Strong knowledge of Good Clinical Practice (GCP), HIPAA, and IRB processes.
• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint, Teams).
• Excellent organizational, analytical, and interpersonal communication skills.
• Ability to manage multiple concurrent projects and multidisciplinary teams.

Preferred Qualifications

• Master’s degree in Health Sciences with 6+ years of related experience.
• Supervisory or leadership experience managing clinical research staff.
• Experience specifically supporting cell and gene therapy or complex biologics studies.
• Clinical research certification (ACRP, SOCRA, or equivalent).
• Familiarity with research platforms such as Epic, REDCap, Qualtrics, or iLab.
• Bilingual proficiency in Spanish and English.

About the Company

Columbia University Irving Medical Center is a leading academic medical center dedicated to advancing medicine through groundbreaking research and exceptional patient care. The CICET Cell & Gene Therapy Trials Management team focuses on the cutting edge of therapeutic innovation.