Clinical Data Management Specialist

Job Summary

Leading data management activities for clinical studies, the full-time remote Principal Specialist, Clinical Data Management will oversee data processes, collaborate with cross-functional teams, and ensure high-quality data for regulatory submissions and safety reporting.

Key responsibilities

• Oversee and manage data management activities for assigned clinical studies, including First-In-Human studies
• Collaborate with Clinical Operations, Safety, and Biostatistics teams to support timely decision-making and governance
• Develop and implement data management processes, policies, and training for internal staff and external partners

Required qualifications

• BS/BA in computer science or related discipline with 8+ years of experience in the Pharmaceutical Industry, or equivalent advanced degree with relevant experience
• Thorough understanding of the drug development process and experience with GCP and CDISC/CDASH/SDTM standards
• Hands-on clinical database programming skills, including SAS, SQL, and Medidata Rave Architect
• Experience in developing SOPs/Work Instructions and familiarity with FDA guidance documents
• Proven leadership experience, including supervisory roles and project management skills