Remote Associate Director, Data Management

Otsuka America Pharmaceutical Inc.; Nashville (TN); 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 the Clinical Analytics department, guiding strategies and operations for clinical data handling.

You will line-manage Protocol Data Managers, drive quality and performance targets, manage budgets and vendors, and ensure compliance with ICH GCP and CDASH while advancing data capture technologies.

Qualifications

• Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in pharmaceutical industry.
• Deep understanding of ICH GCP guidelines, CDASH standards, and other regulatory rules.
• Experience leading data management teams and managing budgets/resources.
• Strong communication and stakeholder management.

Responsibilities

• Develop data management strategies and methodologies to support projects.
• Drive continual improvement across a program and share lessons learned.
• Represent Clinical Data Management on governance teams and manage scope/budget/resources.
• Develop and maintain SOPs and collaborate across functions.
• Provide risk mitigation and cross-functional communication.
• Evaluate EDC and other data capture technologies for implementation.
• Mentor and train DM staff and oversee direct reports.

Skills

Project management

Leadership

Vendor management

Regulatory compliance

ICH GCP/CDASH

Communication

Strategic thinking

Risk management

Team development

Education

Bachelor’s or Master’s degree (preferred)

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the data management team within the Clinical Analytics department, guiding strategies and operations for clinical data handling.

You will line-manage Protocol Data Managers, drive quality and performance targets, manage budgets and vendors, and ensure compliance with ICH GCP and CDASH while advancing data capture technologies.