Executive Director, Clinical Data Systems

Overview

• Lead strategic and operational leadership for clinical data acquisition across phases I-IV.
• Develop and maintain policies, procedures, and data standards for clinical studies.
• Maximize usage of Electronic Data Capture systems for high-quality data collection.
• Manage external vendors ensuring controlled and compliant data delivery methods.
• Represent Clinical Data Management in leadership capacities within the organization.
• Collaborate with senior leaders across R&D for efficient and compliant work delivery.
• Drive innovation and efficiency in data collection processes and deliverables.
• Ensure adherence to global regulatory requirements and company policies.
• Develop and manage departmental and study budgets effectively.

Key Responsibilities & Duties

• Define and drive vision for optimized clinical data collection using advanced technologies.
• Oversee end-to-end management of clinical data acquisition activities.
• Provide leadership to the Clinical Data Acquisition team ensuring proactive engagement.
• Maintain oversight of record retention strategies for clinical data and documentation.
• Drive quality, efficiency, and innovation in data collection deliverables.
• Establish governance structures for effective vendor quality oversight.
• Lead data standardization initiatives ensuring compliance with regulations and standards.
• Develop continuous process improvement strategies for study deliverables.
• Support regulatory submissions and inspections with robust oversight processes.

Job Requirements

• Bachelor's degree in a related discipline with 18+ years of experience.
• Extensive experience in Biotech/Pharmaceutical industry, preferably in Oncology clinical trials.
• Demonstrated success in leading global data management and technical teams.
• Experience with regulatory submissions and inspections is required.
• Strong understanding of clinical development, quality, and regulatory standards.
• Proven ability to lead major change initiatives and manage external vendors effectively.
• Knowledge of CDISC standards and Good Clinical Practices (GCP) is essential.
• Excellent analytical and business communication skills.
• Ability to inspire and influence teams through rapidly changing business challenges.