Senior Data Management Lead, Clinical Trials (Remote)

Travere Therapeutics; Manchester (NH); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with employer match

Job summary

Travere Therapeutics is seeking an Associate Director of Data Management in San Diego, with remote possibilities not required, to lead data management for multiple trials. The role emphasizes leadership of DM deliverables, collaboration with CROs, and ensuring data integrity for regulatory submissions.

The position requires a Bachelor’s in life science and 8+ years of DM experience, with strong knowledge of CDASH/SDTM and ICH/GCP guidelines.

Qualifications

• Bachelor's degree in life science or related field; equivalent combination of education and experience considered.
• 8+ years of direct Data Management experience required.

Responsibilities

• Lead data management deliverables within development programs.
• Develop and maintain data management timelines for programs.
• Oversee data management in audits and regulatory inspections.
• Coordinate with Study Management Team on DM activities.
• Manage CROs/vendors to ensure trial data integrity and timely delivery.
• Review data for protocol deviations and data quality issues.
• Ensure SDTM/ADaM standard terminology usage across datasets.

Skills

Data Management Leadership

CRO/Vendor Management

CDASH/SDTM

EDC Systems

Data Quality

Education

Bachelor's degree in life science

8+ years data management experience

Tools

Medidata RAVE

Job description

Travere Therapeutics is seeking an Associate Director of Data Management in San Diego, with remote possibilities not required, to lead data management for multiple trials. The role emphasizes leadership of DM deliverables, collaboration with CROs, and ensuring data integrity for regulatory submissions.

The position requires a Bachelor’s in life science and 8+ years of DM experience, with strong knowledge of CDASH/SDTM and ICH/GCP guidelines.