Data Management Leader - Clinical Analytics

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

Benefits offered by this job

401(k) matching program

Comprehensive medical/dental/vision

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. in Austin, TX, seeks an Associate Director of Data Management to lead the data management team within Clinical Analytics. You will guide protocol data managers, oversee budgets and resources, and ensure regulatory compliance and data quality across trials.

The role emphasizes leadership, mentorship, risk management, and collaboration with cross-functional partners to deliver high-quality data for clinical development and decision making.

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%).

Responsibilities

• Act as Data Management expert to develop data management strategies and methodologies across programs.
• Drive continual improvement and share best practices across projects/programs.
• Represent Clinical Data Management on governance teams.
• Manage scope, budget, and resources for assigned projects/programs.
• Develop and maintain SOPs and working practice documents for data management tasks.
• Identify risks and implement mitigation strategies.
• Ensure data capture, management, and review standards meet regulatory requirements.
• Provide consultation and leadership to clinical development on data handling and processes.
• Evaluate EDC and other data collection technologies for implementation.
• Develop and maintain standard eCRFs and edit specs.
• Represent data management in key company initiatives.
• Manage external vendors and oversight of deliverables.
• Participate in new hire, onboarding, mentoring and training of DM staff.
• Line management and performance expectations for direct reports.

Skills

Project management

People management

Vendor management

Data management in clinical trials

ICH/GCP & CDASH knowledge

Organization & time management

Regulatory audits & inspections

Communication & presentation

Oversight of CROs & vendors

Travel coordination

Education

Bachelor's or Master's degree

Job description

Otsuka America Pharmaceutical Inc. in Austin, TX, seeks an Associate Director of Data Management to lead the data management team within Clinical Analytics. You will guide protocol data managers, oversee budgets and resources, and ensure regulatory compliance and data quality across trials.

The role emphasizes leadership, mentorship, risk management, and collaboration with cross-functional partners to deliver high-quality data for clinical development and decision making.