Senior Data Management Leader – Clinical Trials

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

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Paid holidays & paid leave

Flexible time off

Job summary

Otsuka America Pharmaceutical Inc. in Dover, Delaware, seeks an Associate Director of Data Management to lead the Clinical Analytics DM team and drive data management strategy across programs.

You will oversee line management, risk mitigation, and training, ensuring quality, regulatory compliance, and timely delivery for global clinical trials. This role requires ~20% travel and strong cross-functional collaboration.

Qualifications

• Strong program-level data management leadership and budgeting
• Experience with regulatory audits/inspections and CRO oversight
• Knowledge of CDASH standards and regulatory guidelines (ICH GCP)
• Proven ability to manage external vendors and drive process improvements
• Excellent communication and cross-functional collaboration skills

Responsibilities

• Develop data management strategies for programs and projects
• Lead DM staff with line management and performance expectations
• Represent DM on governance teams and with cross-functional partners
• Manage scope, budget, and resources for assigned programs
• Evaluate and implement data capture technologies (EDC) and standard eCRFs

Skills

Program leadership

Vendor management

Clinical data management

ICH GCP & CDASH

Regulatory compliance

Communication skills

Mentoring

Education

Bachelor’s or Master’s degree in CDM (preferred)

Tools

EDC systems

Job description

Otsuka America Pharmaceutical Inc. in Dover, Delaware, seeks an Associate Director of Data Management to lead the Clinical Analytics DM team and drive data management strategy across programs.

You will oversee line management, risk mitigation, and training, ensuring quality, regulatory compliance, and timely delivery for global clinical trials. This role requires ~20% travel and strong cross-functional collaboration.