Director of Clinical Data Management

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 169,000 - 253,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director of Data Management to lead the Clinical Analytics DM team, shape data handling strategies, and ensure high-quality data for clinical programs. This leadership role drives risk management, SOP development, and cross-functional collaboration across projects.

The position emphasizes FDA/ICH compliance, budget and resource oversight, and mentorship of Protocol Data Managers, with travel ~20% as needed.

Qualifications

• 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%)
• Educational Qualifications

Responsibilities

• Develop data management strategies and methodologies to support projects.
• Drive continual program improvement and share best practices across programs.
• Represent DM on governance teams and joint operations committees.
• Manage scope, budget, and resources for projects/programs.
• Develop SOPs and practices for data management across functions.
• Identify risks and implement mitigation strategies.
• Maintain timely communication with management and cross-functional teams.
• Establish data capture, management, and review standards in compliance with global regulations.
• Provide consultation and leadership in data handling and management processes.
• Evaluate EDC and other data collection technologies for implementation.
• Contribute to standard eCRFs and edit specifications.
• Represent data management on key company initiatives.
• Oversee external vendors and deliverables.
• Participate in new hire, onboarding, mentoring and training of DM staff.
• Line management and performance expectations for direct reports.
• Other tasks as assigned.

Skills

Project management

Leadership

Vendor management

Data management processes

ICH GCP & CDASH

Regulatory audits

Communication

Cross-functional collaboration

Education

Bachelor’s or Master’s degree

Tools

EDC systems

Job description

Otsuka Pharmaceutical Co., Ltd. seeks an Associate Director of Data Management to lead the Clinical Analytics DM team, shape data handling strategies, and ensure high-quality data for clinical programs. This leadership role drives risk management, SOP development, and cross-functional collaboration across projects.

The position emphasizes FDA/ICH compliance, budget and resource oversight, and mentorship of Protocol Data Managers, with travel ~20% as needed.