Humaneva Group
Humaneva Group
1,001 – 5,000 Employees
B2BHealthcarePharmaceuticals
Humaneva Group is a healthcare and pharmaceutical organization focused on clinical research and the generation of dependable data for the medical community. Its connected operating model brings together a clinical research site network, a contract research organization, and a technology platform, linking patients, investigators, research centers, and data standards across the research process. The Group combines clinical operations, scientific innovation, and data-driven technology, with work that includes therapeutic areas such as oncology.

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.

Description

  • 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

Requirements

  • 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

Benefits

  • Employee employment status

Related Jobs