Lead Clinical Data Manager

Job Summary

Serving as the primary Data Management resource on clinical studies, the full-time Lead Clinical Data Manager will manage data activities from study start-up through database lock, oversee vendor performance, and ensure compliance with data standards in a remote work environment.

Key Responsibilities

• Coordinate Data Management activities with sponsors, CROs, and cross-functional teams for assigned studies
• Manage the full study lifecycle of clinical data activities, including database setup, query management, and data cleaning
• Oversee CRO and EDC vendor performance, ensuring adherence to SOPs, timelines, and quality standards

Required Qualifications

• BA/BS degree in a scientific discipline, nursing, business, or information systems, with 7-10+ years of clinical data management experience
• Advanced knowledge of EDC systems and clinical data structures
• Experience overseeing CRO and EDC vendor performance and deliverables
• Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practice
• Oncology experience and knowledge of RECIST/RANO response criteria