Data Management Lead, Clinical Programs

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Tuition reimbursement

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within Clinical Analytics. You will oversee Protocol Data Managers, drive program-level data strategies, and ensure quality, performance, and training targets are met across projects.

You will coach and line-manage DM staff, collaborate with cross-functional teams, and manage external vendors. Travel ~20% is required; strong leadership and regulatory knowledge are essential.

Qualifications

• Demonstrated project management experience with ability to perform under tight timelines while balancing priorities
• Management skills to lead others and maintain relationships
• Experience with external service providers/vendors
• Knowledge of data management for clinical trials and regulations
• Deep understanding of ICH GCP and CDASH standards
• Experience with regulatory audits/inspections

Responsibilities

• Act as Data Management expert to develop data management strategies at program level
• Identify and implement methodologies and technologies to support projects
• Drive continual improvement across a program and share lessons learned
• Represent Clinical Data Management on governance teams
• Manage scope, budget, and resources for assigned programs
• Develop SOPs and data management guidelines in collaboration with other functions
• Identify risks and implement mitigation strategies
• Maintain timely communication with management and cross-functional teams
• Establish data capture, management, and review standards for regulatory data integrity
• Provide consultation to clinical development on data handling
• Evaluate EDC and other data collection tech for implementation
• Develop and maintain standard eCRFs and edit specs
• Represent data management on company initiatives
• Manage external vendors and oversee deliverables
• Participate in new hire process, onboarding, mentoring and training of DM staff
• Line management and performance expectations for direct reports
• Other tasks as assigned

Skills

Project management

People management

Vendor management

Regulatory knowledge

ICH GCP/CDASH

Audits & inspections

Education

Bachelor’s or Master’s in a relevant field

Tools

EDC systems

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within Clinical Analytics. You will oversee Protocol Data Managers, drive program-level data strategies, and ensure quality, performance, and training targets are met across projects.

You will coach and line-manage DM staff, collaborate with cross-functional teams, and manage external vendors. Travel ~20% is required; strong leadership and regulatory knowledge are essential.