Associate Director Clinical Data Management Program Lead

What you'll do

• Lead the strategic management of clinical data management (CDM) deliverables across assigned programs.
• Communicate program status, risks, and issues to collaborators while developing proactive mitigation strategies.
• Provide CDM expertise during protocol design, study start-up, and study conduct to ensure consistent standards.
• Oversee program timelines, resources, and budgets while serving as the primary escalation point for issues.
• Track metrics and KPIs while managing Quality Events, CAPAs, and process deviations.
• Drive inspection readiness and coordinate CDM activities during regulatory inspections.
• Mentor and coach team members through recruitment, development, and performance management.

What we're looking for

• Bachelor's degree in Mathematics, Science, or a related field.
• 10+ years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
• 5+ years of people management experience.
• Solid understanding of 21 CFR Part 11, ICH-GCP guidelines, and CDISC standards for data collection.
• Proven record of leading studies and study teams in a matrix environment.
• Strong problem-solving, project management, and communication skills.
• Certified Clinical Data Manager (CCDM) certification (preferred).