Associate Director, Data Management

Job Summary

Otsuka is a healthcare company driven by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Associate Director of Data Management supports the Director in providing leadership, direction, and operational management for the data management team. This is a leadership position responsible for line managing, developing and accountability for the Protocol Data Managers in their assigned program;

and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and training.

• At a program level, act as Data Management expert to develop data management strategies,
• identify and implement methodologies and technologies to best support projects.
• Drive continual improvement across a program and effectively share lessons learned and best practices across projects/programs.
• Represent Clinical Data Management on the program governance teams / joint operations committees
• Manage the scope, budget, and resources for assigned projects/programs.
• Develop and maintain SOPs and working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
• Proactively identify risks and executes risk mitigation strategies.
• Maintains timely communication with management and cross-functional teams.
• Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
• Provide consultation, leadership, and expertise to clinical development functions in the areas of data handling and data management processes.
• Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.
• Participate in the development and maintenance of standard eCRFs and associated edit specifications.
• Represent data management on key company initiatives.
• Manage external vendors and provide oversight on their deliverables
• Participate in new hire process, onboarding activities, mentoring and training of DM staff.
• Line management and setting performance expectations for assigned direct reports.
• Other tasks as assigned.

Knowledge/

Experience and Skills:

• Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities
• Management skills to accomplish work through others and maintain appropriate relationships
• Experience working with and managing external service providers/vendors
• Working knowledge of data management process for clinical trials and current regulations
• Deep understanding of ICH GCP guidelines, CDASH standards, and other applicable regulatory rules and guidelines
• Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and programs with excellent attention to detail
• Experience with regulatory audits and inspections
• Excellent communication, interpersonal, and presentation skills
• Provide oversight of CROs and external data vendors
• Travel (approximately 20%)

• Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in pharmaceutical industry

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.