Strategic Associate Director, Data Management (Remote)

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Life insurance

Disability insurance

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks an Associate Director of Data Management to lead the DM team within the Clinical Analytics department. You will supervise Protocol Data Managers, drive data management strategies, and ensure quality, timeliness, and regulatory compliance across projects.

The role requires directing budgets, resources, SOPs, risk mitigation, and cross-functional collaboration with clinical development functions. Travel about 20% is anticipated.

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

• At a program level, act as Data Management expert to develop data management strategies, identify and implement methodologies and technologies to best support projects.
• Drive continual improvement across a program and effectively share lessons learned and best practices across projects/programs.
• Represent Clinical Data Management on the program governance teams / joint operations committees
• Manage the scope, budget, and resources for assigned projects/programs.
• Develop and maintain SOPs and working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
• Proactively identify risks and executes risk mitigation strategies.
• Maintains timely communication with management and cross-functional teams.
• Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
• Provide consultation, leadership, and expertise to clinical development functions in the areas of data handling and data management processes.
• Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.
• Participate in the development and maintenance of standard eCRFs and associated edit specifications.
• Represent data management on key company initiatives.
• Manage external vendors and provide oversight on their deliverables
• Participate in new hire process, onboarding activities, mentoring and training of DM staff.
• Line management and setting performance expectations for assigned direct reports.
• Other tasks as assigned.

Skills

Project management

People management

Vendor management

Clinical data management

Regulatory knowledge

Communication skills

CRO oversight

Travel

Education

Bachelor’s or Master’s degree (preferred)

Tools

EDC systems

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks an Associate Director of Data Management to lead the DM team within the Clinical Analytics department. You will supervise Protocol Data Managers, drive data management strategies, and ensure quality, timeliness, and regulatory compliance across projects.

The role requires directing budgets, resources, SOPs, risk mitigation, and cross-functional collaboration with clinical development functions. Travel about 20% is anticipated.