Senior Data Manager & CDM Lead — Remote

Travere Therapeutics; Columbia (SC); 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 with CROs or in-house, ensuring data quality and regulatory compliance. The role requires leadership of data management deliverables, vendor oversight, and cross-functional collaboration across multiple studies within a program.

The position emphasizes standard data management practices, SDTM/CDASH, and leveraging AI to increase productivity while maintaining timelines and inspection

Qualifications

• Lead data management for clinical programs with CROs.
• Ensure data quality, integrity, and regulatory compliance.
• Develop DM plans and specs.
• Provide guidance on CDISC standards (SDTM/CDASH).

Responsabilités

• Act as the single point of accountability for data management deliverables at an assigned level within a program.
• Lead CDM to manage CROs and third‑party vendors for DM execution.
• Lead CDM to manage data deliverables if sourced internally.
• Manage system integrations across data platforms.
• Review CRO and vendor outputs and file in the Trial Master Plan as appropriate.
• Perform ongoing data review to identify discrepancies and resolutions.
• Review documents from vendors and other departments.
• Create data management process documents (DM plans, data transfer agreements).
• Attend clinical trial project team meetings as lead CDM.

Connaissances

CDM lead

CRO oversight

Data management

EDC systems

Medidata RAVE

SDTM/CDASH

AI in data mgmt

team guidance

Outils

Medidata RAVE

EDC systems

CDMS

Description du poste

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house, ensuring data quality and regulatory compliance. The role requires leadership of data management deliverables, vendor oversight, and cross-functional collaboration across multiple studies within a program.

The position emphasizes standard data management practices, SDTM/CDASH, and leveraging AI to increase productivity while maintaining timelines and inspection