Associate Director Clinical Data Manager

Overview

• Lead clinical data management for complex trials, ensuring high-quality data and regulatory compliance.
• Collaborate with cross-functional teams to maintain data integrity and meet project timelines.
• Oversee vendor relationships, ensuring alignment with study objectives and quality standards.
• Develop and implement comprehensive data management plans and validation processes.
• Ensure adherence to GCP, SOPs, and regulatory requirements throughout data management activities.
• Provide leadership in database design, validation, and implementation for clinical studies.
• Participate in study document reviews, including protocols and statistical analysis plans.
• Support regulatory submissions with high-quality clinical data deliverables.

Key Responsibilities & Duties

• Serve as the Data Management Study Lead for assigned clinical trials.
• Coordinate with stakeholders to ensure timely and accurate data deliverables.
• Manage vendor oversight activities, ensuring adherence to project goals and standards.
• Develop and maintain essential data management documentation and guidelines.
• Oversee data transfer setup, validation, and consistency checks.
• Perform supplemental data reviews and quality checks to ensure accuracy.
• Ensure compliance with CDISC standards and clinical research regulations.
• Lead the development of EDC custom reports and associated outputs.
• Maintain documentation integrity within the trial master file (TMF).

Job Requirements

• Bachelor of Science degree with 10+ years of clinical data management experience.
• Proficiency in EDC systems, CDISC standards, and clinical research regulations.
• Extensive experience managing multiple CROs/vendors in various outsourcing models.
• Strong knowledge of database structures, validation processes, and data visualization technologies.
• Demonstrated ability to lead data management activities for complex clinical studies.
• Excellent interpersonal, communication, and organizational skills.
• Logical thinking, attention to detail, and ability to prioritize tasks effectively.
• Experience with GCP compliance and regulatory requirements.
• Ability to work in a fast-paced environment and manage multiple priorities.