Full Job Description
Associate Director Clinical Data Management Program Lead
Lead the strategic management of CDM activities across assigned clinical programs, ensuring quality, timelines, and budgets are met while collaborating with senior leadership, clinical study teams, external vendors, and collaboration partners.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
• Location: Warren, NJ, Armonk, NY or Tarrytown, NY
• Work model/flexibility: mostly onsite with hybrid flexibility
Discover your role:
• Lead the overall success of CDM deliverables across studies and programs
• Communicate program status, risks, and issues proactively to collaborators and develop mitigation strategies
• Provide CDM expertise during protocol design, study start-up, and study conduct, promoting consistent standards and best practices
• Oversee program timelines, resources, and budgets, and serve as the escalation point for program and study issues
• Track metrics and KPIs, and manage Quality Events, CAPAs, and process deviations
• Represent CDM in review committees, CRO governance, and joint meetings with collaborators
• Drive inspection readiness and coordinate CDM activities during regulatory inspections
• Mentor and coach team members, and, where applicable, manage staff through recruitment, development, and performance management
This role requires:
• 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 and 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, with the ability to motivate virtual teams in a matrix environment
• Strong problem-solving, project management, and communication skills in a fast-paced setting
• Certified Clinical Data Manager (CCDM) certification is preferred
Salary Range (annually)
$157,200.00 - $256,600.00
