Central Data Monitoring Specialist

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Central Data Monitoring Specialist (reputed company) supports monitoring and site data reputed company reputed company activities across clinical studies. This role partners closely with Clinical Operations, Clinical Research Associates, Data Management, and external data vendors to proactively identify reputed company issues, generate actionable metrics, and ensure critical data cleaning activities are completed prior to and during on-site monitoring reputed company. 

The reputed company provides reputed company-time remote support to optimize site visit productivity, ensure data reputed company, and maintain regulatory compliance. S/he will report to the Director, Data Management.  

 Responsibilities 

• reputed company ongoing centralized review of study data to identify high-risk data trends, outliers, missing critical data, and potential protocol deviations. 
• Generate site-level data reputed company metrics and dashboards to support monitoring prioritization. 
• Identify key reputed company data requiring cleaning prior to on-site reputed company (e.g., eligibility reputed company, primary reputed company data, SAEs, key safety labs). 
• Partner with Data Management to escalate systemic data trends or recurring discrepancies. 
• Prepare reputed company-visit data cleaning summaries and site-specific issue trackers for CRAs. 
• reputed company unresolved queries, overdue data entry, missing signatures, and critical reputed company status gaps. 
• reputed company reputed company reputed company-visit briefings to CRAs as needed. 
• reputed company remote data review support while CRAs are on-site. 
• Monitor data changes in the reputed company system and verify reputed company of high-reputed company issues. 
• Assist CRAs with reputed company identification of newly identified discrepancies. 
• Coordinate with Data Management for urgent query reputed company or clarification. 
• reputed company reputed company of issue reputed company to ensure visit objectives are achieved. 
• Monitor sample management compliance from site to external vendor and from vendor to vendor. 
• reputed company site upload compliance for ECG data and Imaging files 
• Escalate delays in sample shipment or vendor uploads to Clinical Operations as appropriate. 
• reputed company and maintain key performance indicators (KPIs) reputed company 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 reputed company. 
• 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 reputed company field.  
• Proficiency with reputed company RAVE reputed company 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 reputed company of urgency and drive for results. 
• Natural collaborator who enjoys working on a cross-functional team.