CDM Lead & Data Quality Strategist (Remote)

Travere Therapeutics; Providence (RI); Hybride; USD 116 000 - 151 000; Plein temps

Résumé du poste

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials, ensuring data quality and regulatory compliance. You will lead data management activities, manage CROs, and drive data integration across platforms in a dynamic development program.

The role requires expertise in CDASH/SDTM, ICH/GCP guidelines, and strong cross-functional collaboration to support publications and regulatory submissions.

Qualifications

• Knowledge of drug development and Clinical Data Management processes.
• Experienced in designing trials with CDASH/SDTM terminology.
• Understanding of ICH/GCP requirements and data standards.

Responsabilités

• Act as single point of accountability for data management deliverables.
• Lead CDM to supervise CROs and vendors for trial delivery.
• Manage data system integrations across platforms.
• Review data for discrepancies and prepare data review specs.
• Develop data management plans and timelines.
• Collaborate cross-functionally and drive database locks.
• Guide team on SOPs, study protocols, and data governance.
• Leverage AI models to improve data efficiencies.

Connaissances

Data management

CDM leadership

CRO oversight

AI in data

EDC systems

Medidata RAVE

Project management

GCP/ICH guidelines

Outils

Medidata RAVE

EDC platforms

Data integration

Description du poste

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials, ensuring data quality and regulatory compliance. You will lead data management activities, manage CROs, and drive data integration across platforms in a dynamic development program.

The role requires expertise in CDASH/SDTM, ICH/GCP guidelines, and strong cross-functional collaboration to support publications and regulatory submissions.