Director, Clinical Data Management

Travere Therapeutics; Columbia (SC); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking an Associate Director of Data Management to lead data management efforts across trials. You will oversee start-up and execution with CROs or in-house, ensure data quality and regulatory compliance, and guide DM professionals while collaborating cross-functionally.

The role emphasizes SDTM/CDASH, vendor management, timeline development, audits, and ensuring inspection readiness in San Diego with hybrid remote

Qualifications

• Bachelor's degree in life science, pharmacy or related field required.
• 8+ years of direct Data Management experience required.

Responsibilities

• Lead DM deliverables within a development program.
• Develop and maintain DM timelines.
• Lead DM in audits and regulatory inspections.
• Act as DM SME at Study Management Team meetings.
• Oversee CROs and vendors for DM.
• Review data for protocol deviations and data quality.
• Cross-functional collaboration in clinical trial teams.
• Plan database locks and deliverables across programs.
• Contribute to SOPs and study protocols from a DM perspective.
• Provide guidance to DM personnel on projects.
• Maintain and archive DM project documentation.
• Monitor progress to meet timelines and budgets.
• Ensure inspection readiness and compliance.
• Travel as necessary (≈10%).
• Experience with CDASH/SDTM terminology and data integrations.

Skills

Data Management

Leadership

Vendor management

CDASH/SDTM

Regulatory compliance

Project management

Cross-functional collaboration

Education

Bachelor's degree in life science or related field

Tools

Medidata RAVE

EDC Systems

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking an Associate Director of Data Management to lead data management efforts across trials. You will oversee start-up and execution with CROs or in-house, ensure data quality and regulatory compliance, and guide DM professionals while collaborating cross-functionally.

The role emphasizes SDTM/CDASH, vendor management, timeline development, audits, and ensuring inspection readiness in San Diego with hybrid remote