Lead Data Manager - Clinical Trials - Remote

Travere Therapeutics; Salt Lake City (UT); Sur place; USD 116 000 - 151 000; Plein temps

Résumé du poste

Travere Therapeutics in San Diego is seeking a Principal Data Manager to lead data management for clinical trials, ensuring high-quality, regulatory compliant data in collaboration with CROs or in-house teams.

The role requires overseeing data management deliverables, vendor oversight, system integrations, and documentation, with a focus on data standards like CDASH/SDTM and ICH/GCP guidelines. Travel up to 10% may be required.

Qualifications

• Knowledge of drug development and Clinical Data Management processes.
• Experience with CDASH/SDTM terminology.
• Understanding of ICH Guidelines and GCP requirements.

Responsabilités

• Act as single point of accountability for data management deliverables.
• Lead CRO/vendor oversight for data management in trials.
• Manage data management deliverables when sourced internally.
• Oversee data review outputs and trial master file documentation.
• Develop and maintain data management plans and specs.
• Collaborate cross-functionally in clinical study teams.

Connaissances

Data management

CDASH/SDTM

ICH Guidelines

GCP

Vendor oversight

Outils

Medidata RAVE

EDC Systems

Data integrations

Description du poste

Travere Therapeutics in San Diego is seeking a Principal Data Manager to lead data management for clinical trials, ensuring high-quality, regulatory compliant data in collaboration with CROs or in-house teams.

The role requires overseeing data management deliverables, vendor oversight, system integrations, and documentation, with a focus on data standards like CDASH/SDTM and ICH/GCP guidelines. Travel up to 10% may be required.