Central Data Monitoring Specialist

<p><span data-contrast="none"><span data-ccp-parastyle="Default" data-ccp-parastyle-defn="{"ObjectId":"272499da-5523-5969-b17c-4f82c0ce3910|1","ClassId":1073872969,"Properties":[469775450,"Default",201340122,"2",134233614,"true",469778129,"Default",335572020,"1",469777841,"Times New Roman",469777842,"Times New Roman",469777844,"Times New Roman",469769226,"Times New Roman",335551500,"0",268442635,"24",335559740,"240",201341983,"0",335559739,"0",201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777843,"Calibri",201341986,"1"]}">Priovant</span><span data-ccp-parastyle="Default"> is committed to developing therapies that address high unmet need in autoimmune disease. </span><span data-ccp-parastyle="Default">The Central Data Monitoring Specialist (CDMS) supports monitoring and site data quality oversight activities across clinical studies. This role partners closely with </span><span data-ccp-parastyle="Default">Clinical Operations, </span><span data-ccp-parastyle="Default">Clinical Research Associates, Data Management, and external data vendors to proactively </span><span data-ccp-parastyle="Default">identify</span><span data-ccp-parastyle="Default"> key data issues, generate actionable metrics, and ensure critical data cleaning activities are completed prior to and during on-site monitoring visits.</span></span><span data-ccp-props="{"201341983":0,"335559739":6,"335559740":240}"> </span></p> <p><span data-contrast="none"><span data-ccp-parastyle="Default">The CDMS</span><span data-ccp-parastyle="Default"> </span><span data-ccp-parastyle="Default">provid</span><span data-ccp-parastyle="Default">es</span><span data-ccp-parastyle="Default"> real-time remote support to </span><span data-ccp-parastyle="Default">optimize</span><span data-ccp-parastyle="Default"> site visit productivity, ensure data integrity, and </span><span data-ccp-parastyle="Default">maintain</span><span data-ccp-parastyle="Default"> regulatory compliance.</span><span data-ccp-parastyle="Default"> </span><span data-ccp-parastyle="Default">S/he</span><span data-ccp-parastyle="Default"> will </span><span data-ccp-parastyle="Default">report to the </span><span data-ccp-parastyle="Default">Director, Data Management</span><span data-ccp-parastyle="Default">. </span></span><span data-ccp-props="{"201341983":0,"335559739":6,"335559740":240}"> </span></p> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span><strong><span data-contrast="auto">Responsibilities</span></strong><span data-ccp-props="{"335559739":0}"> </span></p> <ul> <li><span data-contrast="auto">Perform ongoing centralized review of study data to identify high-risk data trends, outliers, missing critical data, and potential protocol deviations.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Generate site-level data quality metrics and dashboards to support monitoring prioritization.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Identify key priority data requiring cleaning prior to on-site visits (e.g., eligibility criteria, primary endpoint data, SAEs, key safety labs).</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Partner with Data Management to escalate systemic data trends or recurring discrepancies.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Prepare pre-visit data cleaning summaries and site-specific issue trackers for CRAs.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Highlight unresolved queries, overdue data entry, missing signatures, and critical form status gaps.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Provide structured pre-visit briefings to CRAs as needed.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Provide remote data review support while CRAs are on-site.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Monitor data changes in the EDC system and verify resolution of high-priority issues.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Assist CRAs with rapid identification of newly identified discrepancies.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Coordinate with Data Management for urgent query generation or clarification.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Track progress of issue resolution to ensure visit objectives are achieved.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Monitor sample management compliance from site to external vendor and from vendor to vendor.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Track site upload compliance for ECG data and Imaging files</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335557856":16777215,"335559740":240}"> </span></li> <li><span data-contrast="auto">Escalate delays in sample shipment or vendor uploads to Clinical Operations as appropriate.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Develop and maintain key performance indicators (KPIs) related to:</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span> <ul> <li><span data-contrast="auto">Query aging</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Data entry timeliness</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Critical data completeness</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">External data reconciliation</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Site compliance trends</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> </ul> </li> <li><span data-contrast="auto">Contribute to study-level risk review meetings and cross-functional data review forums.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Support inspection readiness by maintaining documentation of centralized review activities and sponsor oversight.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Good working knowledge of ICH, FDA and GCP regulations and guidelines</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="Default">Qualifications </span></span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">Bachelor’s degree in one of the life sciences, or equivalent knowledge and experience.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">2+ years of experience in biopharmaceutical industry or related field. </span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Proficiency with Medidata RAVE EDC system.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Experience in clinical data review.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Experience with sample management and supporting central lab, ECG, imaging, or other external vendor data reconciliation preferred.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Organized and thorough with attention to details.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results.</span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> <li><span data-contrast="auto">Natural collaborator who enjoys working on a cross-functional team. </span><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></li> </ul>