Clinical Data Management Lead

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

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within Clinical Analytics. You will manage Protocol Data Managers, drive data strategies, and ensure quality and regulatory compliance across programs.

The role requires strong PM skills, vendor oversight, and mentorship of staff. The position emphasizes leadership, budget and resource management, and collaboration with cross-functional teams to deliver robust data solutions for clinical

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 attention to detail.

Responsibilities

• Provide leadership and accountability for Protocol Data Managers in assigned program.
• Develop data management strategies and identify technologies to support projects.
• Drive continual improvement and share lessons across programs.
• Manage scope, budget, and resources for projects/programs.
• Establish data capture, management, and review standards compliant with regulatory requirements.
• Oversee CROs and external data vendors and mentor DM staff.

Skills

Project management

Leadership

Vendor management

Regulatory knowledge

ICH GCP & CDASH

Communication

Education

Bachelor’s or Master’s degree

Tools

EDC systems

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director of Data Management to lead the DM team within Clinical Analytics. You will manage Protocol Data Managers, drive data strategies, and ensure quality and regulatory compliance across programs.

The role requires strong PM skills, vendor oversight, and mentorship of staff. The position emphasizes leadership, budget and resource management, and collaboration with cross-functional teams to deliver robust data solutions for clinical