Assistant Regulatory Manager – Clinical Trials Compliance Lead

Columbia University in the City of New York; Fort Lee (NJ); Híbrido; USD 85.000 - 91.000; Jornada completa

Descripción de la vacante

Columbia University in the City of New York's Fort Lee, NJ campus seeks an Assistant Regulatory Manager to help oversee regulatory functions across disease groups in the CPDM Office. The role requires mastery of local, federal, and international regulations and experience with FDA, ICH-GCP, and IRB processes.

The position reports to the Regulatory Manager and may supervise a small team. Flexible/hybrid work arrangements may be discussed during interviews.

Formación

• Bachelor’s Degree or equivalent plus three years of related experience.
• Experience in clinical research with ICH-GCP and CFR guidelines preferred.
• Excellent interpersonal and organizational skills required.
• Proficiency with MS Office applications essential.
• Clinical Research Professional certification (ACRP/RAPS/PRIM&R CIP or SOCRA) preferred.

Responsabilidades

• Coordinate regulatory activities for the CPDM and supervise staff.
• Conduct department-wide regulatory trainings to promote compliance.
• Monitor workload and implement quality control mechanisms.
• Prepare for sponsor audits and federal inspections.
• Assist in developing SOPs and special projects.

Conocimientos

Regulatory management

Staff supervision

Training delivery

Documentation & compliance

Educación

Bachelor’s Degree or equivalent

Herramientas

MS Office (Word, Excel, PowerPoint)

Descripción del empleo

Columbia University in the City of New York's Fort Lee, NJ campus seeks an Assistant Regulatory Manager to help oversee regulatory functions across disease groups in the CPDM Office. The role requires mastery of local, federal, and international regulations and experience with FDA, ICH-GCP, and IRB processes.

The position reports to the Regulatory Manager and may supervise a small team. Flexible/hybrid work arrangements may be discussed during interviews.