Senior Data Manager Clinical Trials Leadership (Remote)

Travere Therapeutics; Denver (CO); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health benefits

Stock options

Paid time off

Job summary

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee data management start-up and execution for clinical trials, ensuring high-quality, regulatory-compliant data for publications and submissions.

The role leads CROs, manages internal data deliverables, and drives data integrations across platforms, with a focus on SDTM/CDASH and UAT processes. Strong leadership and communication are essential.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes.
• Experience in designing trials using CDASH and SDTM terminology.
• Understanding of ICH Guidelines and GCP Requirements.

Responsibilities

• Act as the single point of accountability for data management deliverables.
• Lead CDM to oversee CROs and vendors for study data management.
• Manage data management deliverables when sourced internally.
• Coordinate system integrations across data platforms.
• Review data review outputs and file in Trial Master Plan.
• Identify data discrepancies and drive resolutions.
• Review protocol deviations and perform UAT of databases.
• Create data management documents (DMP, data transfer, workflows).
• Work cross-functionally with other departments on trial projects.
• Plan database locks and multiple deliverables across studies.
• Contribute to SOPs and study protocols from a data perspective.
• Leverage AI models to increase productivity.

Skills

CDM leadership

Data management

Data quality assurance

Vendor management

CRO oversight

AI for data

Communication

Project management

SDTM/CDASH

Medidata RAVE

Tools

Medidata RAVE

EDC systems

Data integration

Job description

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee data management start-up and execution for clinical trials, ensuring high-quality, regulatory-compliant data for publications and submissions.

The role leads CROs, manages internal data deliverables, and drives data integrations across platforms, with a focus on SDTM/CDASH and UAT processes. Strong leadership and communication are essential.