Associate Director, Clinical Data Management

Overview

• Lead clinical data management activities for multiple studies, ensuring accurate and complete data for analysis and regulatory submission.
• Oversee vendor partnerships and ensure compliance with performance metrics and timelines.
• Develop and maintain clinical trial databases adhering to industry standards and regulatory requirements.
• Coordinate data review and validation processes to ensure data consistency and accuracy.
• Support regulatory submissions by ensuring complete and accurate clinical trial documentation.
• Provide leadership and training to the data management team, fostering professional growth.
• Contribute to departmental SOP development and quality assurance processes.
• Collaborate with cross-functional teams to ensure high-quality data output and adherence to project timelines.

Key Responsibilities & Duties

• Act as the data management lead for clinical studies, overseeing database setup through closeout.
• Manage vendor partnerships and ensure adherence to performance metrics and deliverables.
• Review protocols and study documents to ensure accurate data capture and compliance.
• Coordinate data review processes and ensure audit-ready project documentation.
• Develop and track internal performance metrics for data management activities.
• Support clinical documentation preparation for regulatory submissions.
• Assist in departmental resource planning and performance evaluations.
• Ensure compliance with GCP, SOPs, and regulatory requirements in all data management activities.

Job Requirements

• Bachelor’s Degree in Science or related field required.
• Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry.
• Advanced knowledge of data management processes, systems, and regulatory requirements.
• Proficiency in setting up clinical databases in Medidata Rave.
• Strong organizational skills to manage projects, timelines, and budgets effectively.
• Excellent written and verbal communication skills.
• Ability to travel domestically and internationally up to 20%.
• Self-motivated, adaptable, and resourceful in a fast-paced environment.