Senior Data Management Lead - Clinical Trials (Remote)

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Job summary

Ideal candidates have 8+ years in DM, strong vendor and project management skills, and deep knowledge of CDASH/SDTM and ICH/GCP guidelines. Remote-friendly with emphasis on San Diego operations.

Qualifications

• Bachelor's degree in life science or related field; 8+ years of Data Management experience.
• Experience leading data management for clinical trials and vendor management.
• Strong communication and cross-functional collaboration skills.
• Knowledge of CDASH/SDTM terminology and ICH/GCP guidelines.

Responsibilities

• Lead data management deliverables within a development program.
• Maintain data management timelines and oversee CROs.
• Lead data management in audits and regulatory inspections.
• Oversee as DM SME at Study Management Team meetings.
• Ensure data quality and regulatory compliance across programs.
• Develop SOPs and study protocols from a data management perspective.

Skills

Data management leadership

Vendor management

Project management

Cross-functional collaboration

CDASH/SDTM knowledge

Medidata RAVE

ICH/GCP knowledge

EDC systems

AI in data collection

Communication skills

Education

Bachelor's degree in life science or related field

Tools

Medidata RAVE

EDC Systems

Job description

Ideal candidates have 8+ years in DM, strong vendor and project management skills, and deep knowledge of CDASH/SDTM and ICH/GCP guidelines. Remote-friendly with emphasis on San Diego operations.