Senior Director Clinical Data Management

Overview

• Lead the Clinical Data Management department, driving strategic and operational excellence across all phases of clinical studies.
• Develop and implement innovative strategies to enhance productivity and organizational effectiveness in data management operations.
• Collaborate with senior leadership to align data management priorities with broader organizational goals and objectives.
• Represent the department in cross-functional discussions, contributing to strategic decision-making and organizational success.
• Foster a positive and empowering work environment that promotes professional growth and team engagement.
• Ensure compliance with regulatory standards and policies relevant to clinical data management practices.
• Drive talent development initiatives, focusing on leadership growth and performance management within the department.
• Champion innovation and excellence in clinical data management processes and deliverables.

Key Responsibilities & Duties

• Oversee data management activities across all clinical study phases, ensuring quality and efficiency.
• Lead the development and optimization of data management processes, driving innovation and operational improvements.
• Manage and mentor employees, including senior-level staff, to meet current and future business needs.
• Collaborate with cross-functional teams to strengthen coordination and achieve organizational priorities.
• Represent the department in industry forums, establishing the organization as a leader in data management practices.
• Ensure adherence to quality and regulatory standards, including GCP, ICH, and CDISC guidelines.
• Drive initiatives to enhance vendor engagement and optimize resource utilization across the portfolio.
• Develop and analyze performance metrics to continuously raise departmental standards and effectiveness.

Job Requirements

• Bachelor's degree in a related discipline; advanced degrees preferred.
• Minimum of 15 years of related experience; 17 years preferred.
• Extensive experience in the Biotech/Pharmaceutical industry, with a focus on oncology clinical trials.
• Proven leadership in global data management teams and regulatory submissions.
• Strong knowledge of clinical development, quality, and regulatory standards.
• Demonstrated success in managing CROs and driving organizational change initiatives.
• Excellent analytical and business communication skills.
• Ability to develop and train staff on key data management SOPs and guidelines.