Job Title: Sr. Manager/AD Clinical Data Management

Summary:

This position is responsible for leading and overseeing clinical data management activities for clinical trials, ensuring high-quality data deliverables, and collaborating with cross-functional teams to support clinical development programs.

Responsibilities:

• Lead and manage all aspects of clinical data management for assigned clinical studies, ensuring data integrity and compliance with regulatory requirements.
• Develop and implement data management plans, including data collection, cleaning, and validation strategies.
• Oversee the design, testing, and maintenance of electronic data capture (EDC) systems and related tools.
• Collaborate with clinical operations, biostatistics, and other stakeholders to ensure timely and accurate data delivery.
• Monitor data quality metrics and resolve data discrepancies in collaboration with study teams.
• Provide guidance and mentorship to data management staff, fostering professional development and best practices.
• Participate in vendor selection and management for outsourced data management activities.
• Support regulatory submissions by ensuring data is complete, accurate, and audit-ready.

Qualifications:

• Bachelor’s degree in life sciences, health sciences, or a related field; advanced degree preferred.
• Extensive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated leadership experience managing data management teams or projects.
• Strong knowledge of clinical trial processes, GCP, and regulatory requirements.
• Proficiency with EDC systems and clinical data management tools.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work collaboratively in cross-functional teams and manage multiple priorities.
• Experience supporting regulatory submissions is highly desirable.

Published Category: Data Management & Programming