Clinical Data Associate

Vaga não está no LinkedIn

🕒 Outubro 12

🚗 Michigan – Remoto

🚗 Michigan – Remote

💵 $70.000 - $85.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

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Descrição

• Perform comprehensive data management tasks including data review, query generation, and query resolution • Support all study phases: Start-up, Execution, Database Lock, and Close-out • Perform ongoing data reconciliation across all data streams, including EDC, imaging, and third-party vendors • Review discrepancy/edit check output and validation listings per the Data Management Plan • Resolve answered queries and re-query where appropriate • Receive and reconcile imaging data • Manage eCRF freeze/lock activities • File documentation in the Trial Master File • Support study closeout and archiving activities, including QC of subject/site CRFs • Serve as a proficient day-to-day user of the EDC system, including form/field configuration awareness, user access, and data export • Generate EDC reports to track data cleaning progress and outstanding queries • Perform DM quality review and internal QC checks • Support EDC-related testing during study build and amendments • Maintain Power BI dashboards and reports tracking data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings • Translate data management metrics into clear visual reports for internal stakeholders • Maintain and troubleshoot Power Query/Power BI data pipelines • Ensure dashboard data accuracy through reconciliation against EDC source data • Attend study-related meetings and teleconferences • Track project progress and issue periodic status/metric reports • Assist in identifying achievement of milestones per study timelines • Participate in finalization and transfer of the clinical database and related documents to the sponsor • Participate in internal meetings and internal/external audits as required • Maintain awareness of contract scope and study-specific Clinical Data Management Plans

🎯 Requisitos

• Bachelor's degree in a health, science, or related discipline, or equivalent experience in clinical research • Clinical data associate/management experience at a CRO, pharma, medical device, or biotech company • Hands-on experience with EDC systems required (Castor EDC, Rave, Inform, or equivalent) • Demonstrated proficiency managing reports/dashboards in Power BI • Power Query/M language experience is a plus • Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH) • Proficiency with Microsoft Office (Excel, Word) • Strong Excel skills required • Experience working in cross-functional, multi-site clinical trial teams

🏖️ Benefícios

• Great company culture • Opportunities for professional growth • Competitive wages • Benefits

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