Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Central Data Monitoring Specialist (CDMS) supports monitoring and site data quality oversight activities across clinical studies. This role partners closely with Clinical Operations, Clinical Research Associates, Data Management, and external data vendors to proactively identify key data issues, generate actionable metrics, and ensure critical data cleaning activities are completed prior to and during on-site monitoring visits.
The CDMS provides real-time remote support to optimize site visit productivity, ensure data integrity, and maintain regulatory compliance. S/he will report to the Director, Data Management.
Responsibilities
- Perform ongoing centralized review of study data to identify high-risk data trends, outliers, missing critical data, and potential protocol deviations.
- Generate site-level data quality metrics and dashboards to support monitoring prioritization.
- Identify key priority data requiring cleaning prior to on-site visits (e.g., eligibility criteria, primary endpoint data, SAEs, key safety labs).
- Partner with Data Management to escalate systemic data trends or recurring discrepancies.
- Prepare pre-visit data cleaning summaries and site-specific issue trackers for CRAs.
- Highlight unresolved queries, overdue data entry, missing signatures, and critical form status gaps.
- Provide structured pre-visit briefings to CRAs as needed.
- Provide remote data review support while CRAs are on-site.
- Monitor data changes in the EDC system and verify resolution of high-priority issues.
- Assist CRAs with rapid identification of newly identified discrepancies.
- Coordinate with Data Management for urgent query generation or clarification.
- Track progress of issue resolution to ensure visit objectives are achieved.
- Monitor sample management compliance from site to external vendor and from vendor to vendor.
- Track site upload compliance for ECG data and Imaging files
- Escalate delays in sample shipment or vendor uploads to Clinical Operations as appropriate.
- Develop and maintain key performance indicators (KPIs) related to:
- Query aging
- Data entry timeliness
- Critical data completeness
- External data reconciliation
- Site compliance trends
- Contribute to study-level risk review meetings and cross-functional data review forums.
- Support inspection readiness by maintaining documentation of centralized review activities and sponsor oversight.
- Good working knowledge of ICH, FDA and GCP regulations and guidelines
Qualifications
- Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience.
- 2+ years of experience in biopharmaceutical industry or related field.
- Proficiency with Medidata RAVE EDC system.
- Experience in clinical data review.
- Experience with sample management and supporting central lab, ECG, imaging, or other external vendor data reconciliation preferred.
- Organized and thorough with attention to details.
- Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results.
- Natural collaborator who enjoys working on a cross-functional team.