Director, Data Management Reporting

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and specifications across clinical studies. This position involves managing direct reports and/or leading multidisciplinary teams, as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of clinical data programming, external data handling, techniques, standards, methodologies, and skills in working with internal and external systems, CROs, and vendors. Excellent verbal/written communication, analytical, organizational, and interpersonal skills are essential for effective collaboration with individuals at different levels and from diverse disciplines and cultures. Line management experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, handling and processing of raw data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk management.

Responsibilities:

Leadership, Direction, and Strategy:

• Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data listings, sample reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of external data -- acceptance, storage, and delivery activities to ensure complete, high-quality data is available for use by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with data transfer agreements. Manage and oversee the DM programming staff and Functional Service Provider subject matter experts at the functional level to support project portfolio milestones, and/or initiatives to achieve/exceed departmental quality/time/cost objectives.

• Leads development and implementation of DM reporting strategy and solutions at the program level to achieve/exceed quality, time, and cost objectives embracing agile programming methodologies, novel approaches, and industry best practices. Drives execution of the DM programming, reporting, and data visualization activities across all studies to ensure on-time delivery of accurate and high-quality programming deliverables.

• Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiencies to achieve programming operational excellence. Provides strategic input, develops tactical approaches, and proposals to advance DM Data Validation and Reporting initiatives. Leads or participates in departmental and/or multidisciplinary teams working on continuous process improvements and other initiat