Remote: Associate Director, Clinical Data Management

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Paid time off

Job summary

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

This leadership role involves line managing Protocol Data Managers, guiding strategies, and meeting operational targets for quality, performance, and training. You will drive data management strategies, manage budgets, develop SOPs, and collaborate across functions to ensure regulatory-compliant data handling.

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 and methodologies.
• Drive continual improvement across a program and share lessons learned and best practices.
• Represent Clinical Data Management on program governance teams and joint operations committees.
• Manage scope, budget, and resources for assigned projects/programs.
• Develop and maintain SOPs and working practice documents for data management tasks.
• Identify risks and implement risk mitigation strategies.
• Maintain timely communication with management and cross-functional teams.
• Establish data capture, management, and review standards to ensure data quality and regulatory compliance.
• Provide consultation to clinical development in data handling and processes.
• Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.
• Develop and maintain standard eCRFs and edit specifications.
• Represent data management on company initiatives and manage external vendors.
• Participate in onboarding, mentoring and training of DM staff; line management of direct reports.
• Other tasks as assigned.

Skills

Project management

People management

Vendor management

Data management process

ICH GCP & CDASH

Organization & time management

Regulatory audits

Communication skills

Oversight of CROs

Travel 20%

Education

Bachelor’s or Master’s degree (preferred)

Job description

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

This leadership role involves line managing Protocol Data Managers, guiding strategies, and meeting operational targets for quality, performance, and training. You will drive data management strategies, manage budgets, develop SOPs, and collaborate across functions to ensure regulatory-compliant data handling.