Associate Director, Data Management

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the data management team within Clinical Analytics.

This role partners with the Director to guide data handling strategies, manage budgets, and ensure high-quality, compliant data for clinical development programs. The position emphasizes leadership, vendor management, regulatory compliance, and cross-functional collaboration across therapeutic areas, with about 20% travel.

Qualifications

• Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in pharmaceutical industry
• Experience managing data management for clinical trials and familiarity with ICH GCP guidelines, CDASH standards, and regulatory rules
• Proven ability to lead and develop data management staff, manage budgets, timelines, and external vendors
• Strong organizational, communication, and leadership skills with a track record of risk management and audits

Responsibilities

• Provide leadership and direction for the data management team and program-level data strategies
• Manage scope, budget, and resources for assigned projects/programs
• Develop and maintain SOPs and data management standards
• Oversee external CROs and data vendors and monitor deliverables
• Identify and mitigate risks and ensure regulatory compliance
• Mentor and train DM staff and participate in hiring processes

Skills

Project management

Leadership

Vendor management

Regulatory knowledge

Communication

Audits & inspections

Cross-functional collaboration

Travel

EDC systems knowledge

Education

Bachelor’s or Master’s degree (preferred)

Tools

EDC systems

Job description

Job Summary

Otsuka is a healthcare company driven by our purpose and defined by our beliefs. Otsuka DM is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. The Associate Director of Data Management supports the Director in providing leadership, direction, and operational management for the data management team. This is a leadership position responsible for line managing, developing and accountability for the Protocol Data Managers in their assigned program; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and training.

Job Description

• 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.

Qualifications/Required

Knowledge/ Experience and Skills:

• 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%)

Educational Qualifications

• Bachelor’s or Master’s degree (preferred) with a minimum of 10 years of clinical data management experience in pharmaceutical industry

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail] .

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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.