Senior Data Manager, Clinical Trials Lead (Remote)

Travere Therapeutics; Atlanta (GA); On-site; USD 116,000 - 151,000; Full time

Job summary

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials, partnering with CROs or in-house teams to ensure high-quality, regulatory-compliant data for publications and submissions.

You will supervise data management activities, coordinate data integrations, and drive data-driven decisions across multiple studies while adhering to timelines and budgets.

Qualifications

• Experience designing trials with CDASH/SDTM terminology.
• Strong knowledge of ICH/GCP guidelines and regulatory expectations.
• Excellent written and verbal communication across teams.

Responsibilities

• Own data management deliverables for assigned programs.
• Lead CDM to oversee CROs/third-party vendors and ensure datasets meet plans.
• Manage internal data management deliverables when sourced in-house.
• Coordinate data integration across platforms.
• Review CRO/vendor data outputs and file in the Trial Master Plan.
• Perform ongoing data reviews to identify discrepancies and resolutions.
• Review protocol deviations and perform dictionary coding; conduct UAT.
• Develop DM documents: DMP, data transfer agreements, workflows, timelines.
• Collaborate cross-functionally and participate in trial team meetings as lead CDM.
• Plan database locks and deliverables across studies, ensuring consistency.
• Contribute to SOPs and study protocols from a data perspective.
• Explore AI model applications to boost data efficiency.
• Provide guidance to DM personnel on projects.
• Set up and archive data management documentation.

Skills

CDM leadership

Clinical Data Management

SDTM/CDASH design

ICH/GCP knowledge

Medidata RAVE

CRO/vendor management

Data integrations

AI in data management

Project management

Dictionary coding (MedDRA/WHODrug)

Cross-functional collaboration

Travel readiness

Tools

Medidata RAVE

Job description

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials, partnering with CROs or in-house teams to ensure high-quality, regulatory-compliant data for publications and submissions.

You will supervise data management activities, coordinate data integrations, and drive data-driven decisions across multiple studies while adhering to timelines and budgets.