Lead Data Manager - Clinical Trials - Remote

Travere Therapeutics; Salt Lake City (UT); On-site; USD 116,000 - 151,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Data management

CDASH/SDTM

ICH Guidelines

GCP

Vendor oversight

Tools

Medidata RAVE

EDC Systems

Data integrations

Job description

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.