Director, Clinical Data Management

The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency and inspection readiness of clinical databases for subsequent analysis, reporting and regulatory submissions.

Requirements

• Bachelor’s degree in science or related field and a minimum of 10 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
• A proven track record of successful leadership of data management team(s) and vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (ePRO/eCOA) and other database technologies.
• Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
• Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
• Understanding of drug development process and data operations required for the reporting of clinical trial data.
• Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills.
• Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects).

Benefits

• Short- and long-term incentives
• Medical, dental, vision, and retirement savings plans