Associate Director, External Data Quality Management (Pharmaceutical, Remote)

Job summary

This role involves strategic leadership in managing external data quality for clinical trials, ensuring high standards and integrity across clinical programs. The Associate Director will oversee cross-functional teams and vendor performance to enhance trial delivery and decision-making.

Qualifications

• Bachelor’s degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.
• At least 10 years of experience in clinical operations or clinical data management, with 3–5 years in leadership roles.
• Strong understanding of trial conduct and project management.
• Experience in oncology preferred.

Responsibilities

• Lead external data quality and clinical data operational strategy at the portfolio level.
• Ensure consistency in processes and quality expectations across studies and vendors.
• Solve complex operational issues and influence decision-making with strategic insights.
• Oversee acquisition and quality oversight of third-party data sources.
• Collaborate with various departments to ensure aligned execution and readiness.
• Drive continuous improvement initiatives and standardize processes across operations.
• Provide oversight of external vendors and represent data quality management in operational committees.
• Contribute to regulatory submission strategies and ensure compliance with documentation requirements.

Skills

• Strong project management and strategic planning capabilities.
• Excellent problem-solving and critical thinking skills.
• Effective cross-functional communication and alignment.
• Knowledge of EDC systems, ICH-GCP, GDMP, and regulatory expectations.

Education

• Bachelor’s degree required; advanced degree preferred.

Tools

• Familiarity with EDC systems and clinical data management tools.