We have partnered with a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases. Currently, we are searching for a qualified candidate to fill the role of Director of Data Management.
Responsibilities
• Lead all clinical data management activities, ensuring timely milestones.
• Oversee documentation, including DM Plan, CRF Specifications, and Data Transfer Specifications.
• Manage data vendor oversight for consistency, quality, and timeliness.
• Support Inspection Readiness activities, document deviations, and Quality Events.
• Ensure compliance with SOPs, GCP, and ICH guidelines.
Qualifications:
• Minimum of 9 years of clinical data management experience.
• Strong CRO experience
• Oversight and a thorough understanding of regulatory requirements.
• Knowledge of regulations such as ICH, GCP, and privacy rules (HIPAA).
• Excellent interpersonal, leadership, and communication skills.
• Submission experience preferred
