Humaneva Group
Humaneva Group
Humaneva Group — клиникалық зерттеулерге және медицина қауымдастығы үшін сенімді деректер қалыптастыруға бағытталған денсаулық сақтау және фармацевтика ұйымы. Оның өзара байланысқан операциялық моделі клиникалық зерттеу орталықтарының желісін, келісімшарттық зерттеу ұйымын және технологиялық платформаны біріктіріп, зерттеу үдерісі барысында пациенттерді, зерттеушілерді, зерттеу орталықтарын және деректер стандарттарын байланыстырады. Топ клиникалық операцияларды, ғылыми инновацияларды және деректерге негізделген технологияларды ұштастырады; оның жұмысы онкология сияқты терапиялық бағыттарды да қамтиды.

Senior Clinical Data Coordinator at Humaneva Group — India (Remote)

Lead endpoint adjudication and clinical trial data coordination for Humaneva Group in India. Maintain data quality, regulatory compliance, documentation, and collaboration across vendors and study stakeholders.

Сипаттама

  • Manage Endpoint Adjudication Committee activities from case initiation and review through voting and decision-form distribution
  • Check and reconcile clinical trial data for completeness, accuracy, and adherence to study protocols
  • Oversee adjudication case packets and secure source documents within required timelines
  • Create, monitor, and resolve clinical data and adjudication queries
  • Maintain adjudication forms, reports, listings, documentation, and other study materials
  • Create and update CRFs, data management plans, tracking logs, and study records
  • Conduct data review, quality checks, and cleaning activities to protect data integrity
  • Track case progress, study metrics, and operational performance reports
  • Coordinate communication among sponsors, study sites, committee members, vendors, and external stakeholders
  • Manage data transfers and exchanges with vendors, laboratories, and imaging review partners
  • Help design and implement EAC workflows, processes, and operational tools
  • Apply ICH-GCP, regulatory, protocol, and SOP requirements throughout study activities
  • Contribute to study meetings, training sessions, and cross-functional initiatives

Талаптар

  • Master’s degree or PharmD in any discipline required; a Life Sciences background is preferred
  • Four to six years of experience in Clinical Data Management or related work in pharmacovigilance, clinical research, pharmaceutical, or medical device organizations
  • Strong organizational, communication, and time-management abilities
  • Working knowledge of FDA, ICH, and GCP guidance for clinical studies and data management
  • Experience using at least one data management, data collection, or vendor system; exposure to EDC applications is preferred
  • Comfort working effectively in a fast-paced environment

Артықшылықтар

  • Employee employment status

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