Director of Clinical Data Management

Job Summary

To oversee data management activities in support of clinical studies, the full-time remote Director of Clinical Data Management will manage internal expertise, establish outsourcing strategies, and ensure compliance with industry standards while collaborating with cross-functional teams.

Key responsibilities

• Direct and grow internal data management expertise, including managing direct reports
• Establish standards for data management CRO outsourcing strategy and oversee execution of data management activities in clinical studies
• Lead development and implementation of data collection standards and ensure compliance with regulatory requirements

Required qualifications

• BS/BA in a scientific discipline; MS or equivalent preferred, with at least 15 years of clinical data management experience, including 5 years in a leadership role
• Extensive experience managing global studies utilizing an outsourced CDM model
• Expert knowledge of eClinical processes and regulations, including CDISC-SDTM and CDASH standards
• Experience with Medidata Rave EDC systems and familiarity with data visualization systems
• Understanding of ICH GCP and regulatory requirements for clinical data systems, including 21 CFR Part 11