Associate Director, Data Management

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Requirements:

• Bachelor’s degree is required.
• 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry.
• Hands-on knowledge and experience in data management activities, CRF and EDC design, review, and validation.
• Knowledge of SDTM and experience in transforming raw data into these standards.
• Knowledge of GCP, ICH, and regulatory requirements.
• Successful track record of working independently in a matrixed organization.
• Excellent interpersonal communication and organizational skills.

Responsibilities:

• Perform data management study activities and manage timelines during study start-up, conduct, database lock, and documentation archival.
• Conduct oversight of data management CROs to ensure compliance with timelines and data quality standards.
• Oversee and drive development of study-related data management deliverables.
• Participate in the implementation and UAT of clinical systems.
• Coordinate cross-functional data reviews and proactively address data trends and issue resolution.