Head of Clinical Data Management

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Requirements:

• Bachelor's degree in a clinical or life sciences discipline; advanced degree preferred.
• Certified Clinical Data Manager (CCDM) certification is a plus.
• 7+ years of experience in clinical data management for clinical trials.
• At least 3 years in a leadership role managing direct reports.
• Experience with real-world data, including electronic health records.
• Understanding of FDA and ICH regulations related to data management.
• Familiarity with CDISC standards is a plus.
• Strong project management, communication, and problem-solving skills.

Responsibilities:

• Oversee and provide support for the execution of clinical data management activities.
• Develop and implement data management strategies aligned with company goals.
• Continuously improve processes to enhance efficiency and data quality.
• Establish clinical data standards and maintain standard operating procedures.
• Develop study-specific data management plans and ensure compliance with regulatory requirements.
• Lead data reviews and oversee end-to-end data lifecycle for studies.
• Collaborate with internal teams and advise on data management considerations.