Head of Data Management, Clinical Trials (Remote)

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

Benefits offered by this job

Comprehensive medical coverage

Generous 401(k) match

Tuition reimbursement

Paid holidays and paid time off

Job summary

Otsuka America Pharmaceutical Inc. in Montpelier, VT or remote US-based, seeks an Associate Director of Data Management to lead the DM team within Clinical Analytics.

You will partner with cross-functional leaders to drive data strategy, ensure regulatory compliance, and deliver quality data for clinical programs while managing budgets and vendor relationships. This leadership role requires mentorship, performance management, and ongoing process improvement to advance the pipeline and data

Qualifications

• Demonstrated project management experience with tight timelines.
• Management skills to lead teams and external vendors.
• Experience with external service providers/vendors.
• Knowledge of data management in clinical trials and regulations.
• Understanding of ICH GCP, CDASH, and regulatory rules.
• Strong organizational and communication abilities.
• Ability to travel ~20%.

Responsibilities

• Lead and develop the data management team and set performance expectations.
• Develop DM strategies and evaluate data capture technologies.
• Oversee budgets, scope, and resources for programs.
• Maintain SOPs and collaboration with cross-functional teams.
• Identify risks and implement mitigation.
• Represent DM on governance committees.

Skills

Project management

People management

Regulatory knowledge

ICH GCP/CDASH

Communication skills

Vendor management

Cross-functional collaboration

Strategic thinking

Education

Bachelor's or Master's degree in a related field

Job description

Otsuka America Pharmaceutical Inc. in Montpelier, VT or remote US-based, seeks an Associate Director of Data Management to lead the DM team within Clinical Analytics.

You will partner with cross-functional leaders to drive data strategy, ensure regulatory compliance, and deliver quality data for clinical programs while managing budgets and vendor relationships. This leadership role requires mentorship, performance management, and ongoing process improvement to advance the pipeline and data