Director Clinical Data Manager

Overview

• Lead clinical data management operations across Phase I-IV trials, ensuring high-quality database completion and adherence to timelines.
• Provide strategic and executional support within the Data Science & Biometrics organization, driving data quality and completeness.
• Collaborate with cross-functional teams to align clinical data management processes with organizational priorities.
• Develop and implement innovative approaches to enhance productivity and effectiveness in clinical data management.
• Contribute to performance metrics analysis, raising standards at both study and department levels.
• Ensure compliance with quality and regulatory standards, including CDISC and risk-based data management approaches.
• Lead global data management activities and participate in regulatory submissions and inspections.
• Foster a positive, value-based work environment within the clinical data management department.

Key Responsibilities & Duties

• Oversee clinical data management for all trials, utilizing internal and outsourced resources effectively.
• Align with business and functional leaders to execute organizational priorities in clinical data management.
• Optimize resource allocation to support portfolio objectives and ensure workload balance.
• Drive process development and optimization within the clinical data management department.
• Lead initiatives to enhance productivity and effectiveness across the portfolio.
• Ensure adherence to standards and compliance within study teams and department operations.
• Provide guidance and leadership to colleagues in a matrixed organizational structure.
• Maintain strong vendor engagement and utilization to achieve study objectives.

Job Requirements

• Bachelor’s degree in a related discipline with 13+ years of relevant experience; advanced degrees preferred.
• Minimum of 15 years of experience in biotech/pharmaceutical industry, including oncology clinical trials.
• Demonstrated expertise in global data management activities and regulatory submissions.
• Strong understanding of clinical development, quality standards, and regulatory policies.
• Proven ability to lead teams in a matrixed organization and manage CROs effectively.
• Knowledge of Good Clinical Practices (GCP) and risk-based data management approaches.
• Excellent analytical and business communication skills.
• Experience leading change initiatives and driving process optimization.