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Humaneva Group
Humaneva Group
1.001 – 5.000 Angajați
Asistență medicalăB2BProduse farmaceutice
Humaneva Group este o organizație din domeniul sănătății și al produselor farmaceutice, axată pe cercetarea clinică și generarea de date fiabile pentru comunitatea medicală. Modelul său operațional integrat reunește o rețea de centre de cercetare clinică, o organizație de cercetare contractuală și o platformă tehnologică, conectând pacienți, investigatori, centre de cercetare și standarde de date pe parcursul procesului de cercetare. Grupul combină operațiunile clinice, inovația științifică și tehnologia bazată pe date, desfășurând activități în arii terapeutice precum oncologia.
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Locurile de muncă ale companiei

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.

INIndiaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCoordonator de date cliniceGeneral
Google Cloud Platform

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • Employee employment status

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