Remote Associate Director, Clinical Data Management

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

Benefits offered by this job

Comprehensive benefits

401(k) match

Paid time off

Professional development assistance

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management within the Clinical Analytics department to provide leadership, direction, and operational management for the data management team in support of the clinical pipeline.

The role focuses on line management of Protocol Data Managers and ensuring program quality, performance, utilization, and training. This remote, full-time leadership position requires driving program efficiencies, managing budgets and resources,

Qualifications

• Bachelor’s or Master’s degree with minimum 10 years of clinical data management experience.
• Demonstrated project management and vendor management experience.
• Strong knowledge of regulatory guidelines and data governance.
• Experience with ICH GCP, CDASH standards and audits.
• Ability to lead, mentor, and manage cross-functional teams.

Responsibilities

• Act as Data Management expert to develop data management strategies and methodologies.
• Drive continual improvement and share best practices across programs.
• Represent Clinical Data Management on governance teams and committees.
• Manage scope, budget, and resources for assigned projects.
• Develop and maintain SOPs for data management tasks.
• Identify risks and implement mitigation strategies.
• Maintain timely communication with management and cross-functional teams.
• Establish data capture and data management standards for quality data.
• Provide consultation to clinical development on data handling processes.
• Evaluate EDC and other data collection technologies.
• Participate in development of standard eCRFs and edit specs.
• Oversee external vendors and deliverables; mentor DM staff.
• Line manage direct reports and set performance expectations.

Skills

Project management

Vendor management

Regulatory knowledge

ICH GCP / CDASH

Cross-functional collaboration

Communication skills

Risk management

Leadership / line management

Data management processes

Audit experience

EDC familiarity

Education

Bachelor’s or Master’s degree

Tools

Electronic Data Capture (EDC)

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management within the Clinical Analytics department to provide leadership, direction, and operational management for the data management team in support of the clinical pipeline.

The role focuses on line management of Protocol Data Managers and ensuring program quality, performance, utilization, and training. This remote, full-time leadership position requires driving program efficiencies, managing budgets and resources,