Director of Data Management - Remote

Overview

We are seeking a Director of Data Management responsible for both management and technical aspects of Data Management elements of clinical trials.

In Short

• Provide operational leadership for clinical data management.
• Coordinate and review clinical data.
• Ensure quality of clinical data within EDC systems.
• Build effective DM vendor relationships.
• Work closely with CROs for data management activities.
• Review protocols for database feasibility.
• Provide oversight of CRO data management deliverables.
• Ensure compliance with GCP and regulatory requirements.
• Mentor junior data managers.
• Manage documentation and archival standards.

Requirements

• Bachelor’s Degree in health-related field.
• 10 years of clinical data management experience.
• 5 years of people management experience.
• Experience in data design and execution for clinical studies.
• Proficiency in Data Management Systems.
• Knowledge of regulatory requirements.
• Experience managing CROs and data vendors.
• Submission experience (NDA, sNDA, BLAs).
• Knowledge of Good Clinical Practice.
• Excellent communication skills.

Benefits

• Great culture based on C.O.R.E. values.
• Fast-paced, dynamic work environment.
• Market competitive compensation and benefits.
• Flexible PTO.
• Company-wide shutdowns each year.
• Commitment to professional growth.
• Regular in-person team meetings.