Associate Director, Data Management

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

Prescription drug coverage

401(k) match

Paid holidays

Paid time off

Tuition reimbursement

Student loan assistance

Flexible time off

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director of Data Management within the Clinical Analytics group to lead the data management team, oversee protocols, and drive quality, performance, and training across programs. This leadership role includes line management, budgets, vendor oversight, and developing SOPs to ensure regulatory compliance and efficient data handling.

Ideal candidates bring extensive clinical data management experience, strong communication skills, and

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, 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

Leadership

Vendor management

Regulatory knowledge

Data management in trials

ICH GCP / CDASH

Communication

Cross-functional collaboration

Travel readiness

Education

Bachelor’s or Master’s degree

Job description

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

• 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.

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.

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.

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].