Lead, Clinical Data Management Strategy & Operations

Otsuka America Pharmaceutical Inc.; Lincoln (NE); 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 role partners with the Director to guide data handling strategies, manage budgets, and ensure high-quality, compliant data for clinical development programs. The position emphasizes leadership, vendor management, regulatory compliance, and cross-functional collaboration across therapeutic areas, with about 20% travel.

Qualifications

• Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in pharmaceutical industry
• Experience managing data management for clinical trials and familiarity with ICH GCP guidelines, CDASH standards, and regulatory rules
• Proven ability to lead and develop data management staff, manage budgets, timelines, and external vendors
• Strong organizational, communication, and leadership skills with a track record of risk management and audits

Responsibilities

• Provide leadership and direction for the data management team and program-level data strategies
• Manage scope, budget, and resources for assigned projects/programs
• Develop and maintain SOPs and data management standards
• Oversee external CROs and data vendors and monitor deliverables
• Identify and mitigate risks and ensure regulatory compliance
• Mentor and train DM staff and participate in hiring processes

Skills

Project management

Leadership

Vendor management

Regulatory knowledge

Communication

Audits & inspections

Cross-functional collaboration

Travel

EDC systems knowledge

Education

Bachelor’s or Master’s degree (preferred)

Tools

EDC systems

Job description

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

This role partners with the Director to guide data handling strategies, manage budgets, and ensure high-quality, compliant data for clinical development programs. The position emphasizes leadership, vendor management, regulatory compliance, and cross-functional collaboration across therapeutic areas, with about 20% travel.