Senior Clinical Data Coordinator
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Job Description
Senior Clinical Data Coordinator managing endpoint adjudication and clinical trial data. Ensuring data quality, regulatory compliance, and vendor and stakeholder coordination in India.
Responsibilities:
- Coordinate Endpoint Adjudication Committee (EAC) activities, including case initiation, review, voting, and decision form distribution
- Review and reconcile clinical trial data for completeness, accuracy, and protocol compliance
- Manage adjudication case packets and ensure timely collection and submission of source documents
- Generate, track, and resolve clinical data and adjudication-related queries
- Prepare and maintain adjudication documents, forms, reports, listings, and study materials
- Develop and maintain CRFs, data management plans, tracking logs, and study documentation
- Perform data review, quality control, and data cleaning to ensure data integrity
- Monitor case status, study metrics, and operational performance reporting
- Serve as a liaison between sponsors, sites, committee members, vendors, and external stakeholders
- Coordinate data transfers and exchanges with vendors, laboratories, and imaging review partners
- Support the development and implementation of EAC processes, workflows, and operational tools
- Ensure compliance with ICH-GCP, regulatory requirements, study protocols, and SOPs
- Participate in study meetings, training activities, and cross-functional collaborations
Requirements:
- Minimum Master's/Pharm D degree in any discipline; Life Sciences preferred
- At least 4–6 years’ experience in Clinical Data Management or related industry experience in Pharmacovigilance, Clinical Research Coordinators, pharmaceutical or medical device companies
- Strong organizational, communication, and time management skills
- Knowledge of FDA, ICH and GCP guidelines as they apply to clinical studies and clinical data management
- Experience with one or more Data Management/Data Collection Systems/Vendors; some EDC application experience preferred
- Ability to function effectively in a fast-paced environment
Benefits:
- Employee employment status
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