Senior Director Clinical Data Management

Overview

• Lead the Clinical Data Management (CDM) department, ensuring strategic and operational excellence across all clinical studies phases.
• Provide expert knowledge and leadership in CDM concepts, processes, and deliverables within a competitive industry landscape.
• Develop and implement innovative strategies to enhance productivity and organizational effectiveness in CDM operations.
• Collaborate with senior R&D leaders to align CDM priorities with organizational goals and ensure high-quality outcomes.
• Represent CDM in cross-functional discussions and contribute to strategic decision-making processes.
• Foster a positive work environment that promotes employee engagement, empowerment, and professional growth.
• Ensure compliance with regulatory standards and policies relevant to CDM and clinical data management practices.
• Drive talent development initiatives, focusing on leadership growth and performance management within the department.

Key Responsibilities & Duties

• Oversee CDM activities across all clinical studies phases, ensuring efficient resource allocation and quality deliverables.
• Lead the development and optimization of CDM processes, driving innovation and operational improvements.
• Manage and mentor employees, including Director-level staff, to meet current and future business needs.
• Collaborate with cross-functional teams to strengthen coordination and achieve organizational priorities.
• Represent the CDM department in industry forums and contribute to establishing the organization as a leader in CDM 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 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.