Principal Data Manager
Travere Therapeutics
August 25, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
Principal Data Manager overseeing start-up and execution of clinical trials with CROs or in-house teams to ensure data quality, integrity, and regulatory-compliant data supporting publications and regulatory submissions.
Responsibilities:
- Single point of accountability for data management deliverables within a clinical development program.
- Lead CDM oversight of CROs/third-party vendors for data management to completion.
- Lead internal data management deliverables.
- Manage data platform system integrations; ensure review outputs are filed as appropriate in Trial Master Plan.
- Perform ongoing data review to identify discrepancies/trends and drive resolutions.
- Review protocol deviations, dictionary coding, and conduct database user acceptance testing.
- Review vendor and internal documents.
- Create data management process documents (plans, specifications, agreements, workflows, timelines, communications).
- Lead cross-functional meetings; strategize database locks and multi-study deliverables for consistency.
- Provide SOP/protocol input from a data management perspective.
- Use AI models to increase productivity; guide CDM personnel.
- Set up, maintain, and archive project documentation; monitor own activities/status; adhere to budgets/timelines; ensure inspection readiness.
Qualifications / Required & Preferred Skills:
- Knowledge of drug development and clinical data management; guidance experience.
- Clinical trials design using CDASH/SDTM terminology; ICH/GCP knowledge.
- Communication/interpersonal skills.
- EDC system experience; preferred Medidata RAVE.
- Outsourced study/CRO team management experience; data integrations (EDC, IRT, ePRO, lab processing/reconciliation).
- Dictionary coding (MedDRA, WHODrug); project/time management; accountability; travel ~10%; not 100% remote (San Diego onsite as needed).
Benefits:
- Premium health and work-life/well-being offerings; life insurance/disability; retirement match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.
Principal Data Manager overseeing start-up and execution of clinical trials with CROs or in-house teams to ensure data quality, integrity, and regulatory-compliant data supporting publications and regulatory submissions.
Responsibilities:
- Single point of accountability for data management deliverables within a clinical development program.
- Lead CDM oversight of CROs/third-party vendors for data management to completion.
- Lead internal data management deliverables.
- Manage data platform system integrations; ensure review outputs are filed as appropriate in Trial Master Plan.
- Perform ongoing data review to identify discrepancies/trends and drive resolutions.
- Review protocol deviations, dictionary coding, and conduct database user acceptance testing.
- Review vendor and internal documents.
- Create data management process documents (plans, specifications, agreements, workflows, timelines, communications).
- Lead cross-functional meetings; strategize database locks and multi-study deliverables for consistency.
- Provide SOP/protocol input from a data management perspective.
- Use AI models to increase productivity; guide CDM personnel.
- Set up, maintain, and archive project documentation; monitor own activities/status; adhere to budgets/timelines; ensure inspection readiness.
Qualifications / Required & Preferred Skills:
- Knowledge of drug development and clinical data management; guidance experience.
- Clinical trials design using CDASH/SDTM terminology; ICH/GCP knowledge.
- Communication/interpersonal skills.
- EDC system experience; preferred Medidata RAVE.
- Outsourced study/CRO team management experience; data integrations (EDC, IRT, ePRO, lab processing/reconciliation).
- Dictionary coding (MedDRA, WHODrug); project/time management; accountability; travel ~10%; not 100% remote (San Diego onsite as needed).
Benefits:
- Premium health and work-life/well-being offerings; life insurance/disability; retirement match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until a candidate is selected.