Teams at Travere Therapeutics

Executes risk-based GMP and GDP audits across pharmaceutical, biologic, medical device, laboratory, logistics, and distribution suppliers. Evaluates compliance, audit findings, CAPA plans, supplier qualifications, quality events, and regulatory risks. Maintains supplier records and approved supplier lists, supports inspection readiness and quality systems using Veeva Vault, and contributes to procedures and continuous improvement. Requires cross-functional collaboration, strong technical writing, risk assessment, and 25–40% domestic and international travel.

Leads clinical data management for multiple development programs and trials, overseeing CROs, vendors, data quality, integrations, audits, inspections, database locks, regulatory compliance, and study deliverables. Develops timelines, data management plans, SOP inputs, and clinical data review processes. Provides subject matter expertise, mentors data management personnel, supports CDASH and SDTM standards, and manages EDC, IRT, ePRO, laboratory, and other data integrations. Requires independent leadership across cross-functional teams and approximately 10% travel.

Oversee clinical trial data management deliverables from study start-up through completion, ensuring accurate, complete, compliant data for publications and regulatory submissions. Lead CROs and vendors, manage data integrations across EDC, IRT, ePRO, laboratory, and other platforms, review data quality and discrepancies, support coding and user acceptance testing, develop data management documentation, plan database locks, maintain inspection readiness, and provide guidance to data management personnel.