Associate Director/ Senior Manager, Value Evidence and Outcome - Japan

PTC Therapeutics seeks an Associate Director of Clinical Data Management to lead data management activities and oversee clinical database accuracy for rare disease drug development. The role involves strategic planning, vendor oversight, regulatory compliance, and potential supervision of internal staff and external consultants.

Responsibilities

• Provide leadership and oversight of clinical data management activities ensuring database accuracy and consistency
• Develop and implement strategic vision for data management group and EDC system processes
• Collaborate with CROs to prepare data management plans and manage projects end-to-end
• Lead database cleaning, data reconciliation, and lock activities in EDC systems
• Oversee adverse event and medical coding review with coordination of medical monitor approval

Requirements

• Bachelor's degree in science or healthcare-related field
• Minimum 8 years progressive clinical data management experience in pharma, biotech, CRO, or regulatory agency
• Second-line management and functional leadership experience
• Vendor management experience with IWRS, imaging, PRO, and database technologies
• Knowledge of ICH guidelines, CDASH, 21 CFR Part 11, and FDA requirements
• Understanding of drug development and clinical trial data operations
• Strong communication, decision-making, and negotiation skills