Director CDM

Director Clinical Data Management

• Provide strategic leadership and oversight to the clinical data management (CDM) team across multiple therapeutic areas and complex clinical trials.
• Develop and implement data management plans, standards, and procedures to ensure data quality, accuracy, and integrity.
• Collaborate closely with Clinical Operations, Biostatistics, Medical Writing, and Regulatory teams to support clinical trial planning and execution.
• Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory requirements governing clinical data management.
• Mentor, develop, and lead a team of data managers and coordinators, fostering a culture of continuous learning and professional development.
• Review and approve key data management deliverables such as Data Management Plans (DMP), CRF designs, data validation specifications, and study reports.
• Support audits and inspections conducted by regulatory authorities and clients.
• Act as a key point of contact for clients on data management-related matters, ensuring excellent customer service and communication.
• Contribute to business development activities, including proposal writing and client presentations.
• Lead the development and execution of data strategy to align with overall clinical development objectives and timelines.
• Oversee the integration of new technologies, such as AI and machine learning tools, to enhance data quality and efficiency.
• Establish and maintain key performance indicators (KPIs) and metrics to monitor the effectiveness and productivity of the data management function.
• Collaborate with IT and software development teams to customize and optimize clinical data systems and tools.
• Ensure timely resolution of data queries and discrepancies to minimize delays in database lock and study close-out.
• Drive data governance and data privacy initiatives to comply with GDPR, HIPAA, and other data protection regulations.
• Lead cross-functional risk assessments and implement mitigation strategies related to clinical data integrity.
• Represent the clinical data management function in leadership meetings and contribute to strategic planning.
• Support training programs for new hires and provide continuous education to the CDM team to keep pace with industry trends.
• Participate in post-study data review and contribute to the publication of clinical trial results.
• Document lessons learned and best practices to improve future studies.
• Manage timelines, budgets, and resource allocation for the clinical data management department.
• Drive process improvements and implement industry best practices and innovative technologies in data capture, validation, and reporting.
• Oversee vendor selection, management, and performance evaluation for external data management services and EDC providers.

Qualifications: