Associate Director, Data Management
Travere Therapeutics
August 25, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Clinical Research and Development
Associate Director, Data Management
Responsibilities:
- Provide leadership and accountability for data management deliverables within development programs.
- Develop, maintain, and execute data management timelines.
- Lead data management for audits and regulatory inspections.
- Serve as data management subject matter expert at Study Management Team meetings.
- Identify and address gaps in data management processes; champion efficiency improvements.
- Act as Lead CDM to oversee CROs/third-party vendors for successful trial implementation.
- Perform ongoing clinical data review to identify discrepancies, trends, and resolutions.
- Review protocol deviations and manage coding and database user acceptance testing.
- Review vendor and departmental documents; work cross-functionally as Lead CDM.
- Plan database locks and multiple deliverables; provide input on SOPs and study protocols.
- Guide clinical data management personnel; set up, maintain, and archive DM documentation (e.g., DMP, CRF guidelines).
- Monitor project status against timelines, budgets, and inspection readiness.
- Work with minimal supervision.
Qualifications:
- Bachelor’s degree in life science/pharmacy/related field (or equivalent).
- 8+ years of direct Data Management experience.
Required/Preferred skills:
- Prior clinical trial vendor management/integration (preferred: CRO experience; outsourced studies).
- CDASH/SDTM terminology; strong integration experience across data platforms.
- ICH Guidelines, GCP; dictionary coding (MedDRA/WHODrug) and vendor reconciliation.
- EDC systems (preferred: Medidata RAVE); integrations using EDC/IRT/ePRO/external lab processing.
- Ability to manage timelines, complex problems, and multiple projects; communication and judgment.
- Travel ~10%.
- Preferred: experience using AI models for data collection/quality.
Benefits:
- Premium health and financial/work-life/well-being benefits; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until selected.
Responsibilities:
- Provide leadership and accountability for data management deliverables within development programs.
- Develop, maintain, and execute data management timelines.
- Lead data management for audits and regulatory inspections.
- Serve as data management subject matter expert at Study Management Team meetings.
- Identify and address gaps in data management processes; champion efficiency improvements.
- Act as Lead CDM to oversee CROs/third-party vendors for successful trial implementation.
- Perform ongoing clinical data review to identify discrepancies, trends, and resolutions.
- Review protocol deviations and manage coding and database user acceptance testing.
- Review vendor and departmental documents; work cross-functionally as Lead CDM.
- Plan database locks and multiple deliverables; provide input on SOPs and study protocols.
- Guide clinical data management personnel; set up, maintain, and archive DM documentation (e.g., DMP, CRF guidelines).
- Monitor project status against timelines, budgets, and inspection readiness.
- Work with minimal supervision.
Qualifications:
- Bachelor’s degree in life science/pharmacy/related field (or equivalent).
- 8+ years of direct Data Management experience.
Required/Preferred skills:
- Prior clinical trial vendor management/integration (preferred: CRO experience; outsourced studies).
- CDASH/SDTM terminology; strong integration experience across data platforms.
- ICH Guidelines, GCP; dictionary coding (MedDRA/WHODrug) and vendor reconciliation.
- EDC systems (preferred: Medidata RAVE); integrations using EDC/IRT/ePRO/external lab processing.
- Ability to manage timelines, complex problems, and multiple projects; communication and judgment.
- Travel ~10%.
- Preferred: experience using AI models for data collection/quality.
Benefits:
- Premium health and financial/work-life/well-being benefits; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application instructions:
- Apply on an ongoing basis until selected.