Data Management Strategy Director, Clinical Trials

Otsuka America Pharmaceutical Inc.; Juneau (AK); On-site; USD 169,000 - 253,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the data management team within Clinical Analytics.

This senior role reports to the Director and focuses on developing data management strategies, guiding protocols, and ensuring compliance with global regulatory requirements. The position requires strong leadership, program management experience, and the ability to manage internal staff and external CRO vendors while driving high-quality data delivery

Qualifications

• Minimum 10 years of clinical data management experience in the pharmaceutical industry.
• Strong leadership and line-management capabilities.
• Experience working with external CROs/vendors.
• Deep knowledge of ICH GCP guidelines and CDASH standards.
• Ability to manage budgets, scope, and resources for programs.
• Willingness to travel approximately 20%.

Responsibilities

• Develop data management strategies at the program level.
• Identify methodologies and technologies to support projects.
• Drive continual improvement and share lessons learned across projects/programs.
• Represent Clinical Data Management on program governance teams.
• Manage scope, budget, and resources for assigned projects/programs.
• Develop and maintain SOPs for data management tasks in collaboration with other functions.

Skills

Project management

People management

Vendor management

Regulatory knowledge

Communication skills

Education

Bachelor\u2019s or Master\u2019s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the data management team within Clinical Analytics.

This senior role reports to the Director and focuses on developing data management strategies, guiding protocols, and ensuring compliance with global regulatory requirements. The position requires strong leadership, program management experience, and the ability to manage internal staff and external CRO vendors while driving high-quality data delivery