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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.
विवरण
- 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
आवश्यकताएँ
- 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
लाभ
- Employee employment status
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