Remote Associate Director, Data Management (Clinical)

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

Benefits offered by this job

Remote work

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within the Clinical Analytics group. You will guide data management strategies, ensure high-quality data handling across trials, and align with global regulatory requirements.

This remote, full-time leadership role requires line management of Protocol Data Managers, oversight of CROs and external vendors, risk mitigation, and ongoing training to maintain SOPs and compliant practices.

Qualifications

• Demonstrated project management experience with ability to perform under tight timelines.
• Management skills to accomplish work through others and maintain relationships.
• Experience with external service providers/vendors.
• Working knowledge of data management process for clinical trials and regulations.
• Deep understanding of ICH GCP, CDASH standards, and regulatory rules.
• Strong organizational, time management, and resource-allocation skills.
• Experience with regulatory audits and inspections.
• Excellent communication, interpersonal, and presentation skills.
• Oversight of CROs and external data vendors.
• Travel about 20%.

Responsibilities

• Act as Data Management expert to develop data management strategies and methodologies.
• Drive continual improvement across programs and share best practices.
• Represent Clinical Data Management on governance teams and with vendors.
• Manage scope, budget, and resources for projects/programs.
• Develop and maintain SOPs and data management documents with cross-functional teams.
• Identify risks and implement mitigation strategies.
• Ensure data quality and regulatory compliance for clinical data.
• Provide consultation and leadership to clinical development functions.
• Evaluate EDC and data capture technologies for implementation.
• Mentor and train DM staff; line management of direct reports.

Skills

Project management

Team leadership

Vendor management

Clinical data management

ICH GCP & CDASH knowledge

Regulatory compliance

Organization & time management

Audit & inspection experience

Communication & presentation

CRO oversight

Education

Bachelor/Master degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within the Clinical Analytics group. You will guide data management strategies, ensure high-quality data handling across trials, and align with global regulatory requirements.

This remote, full-time leadership role requires line management of Protocol Data Managers, oversight of CROs and external vendors, risk mitigation, and ongoing training to maintain SOPs and compliant practices.