Key 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.

Education, Skill & Experience:

• Minimum Master's/Pharm D degree in any discipline. Life Sciences is 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.

• Solid organizational, communication, and time management skills required.

• 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.

📌 Senior Clinical Data Coordinator (India)
🏢 Humaneva Group
📍 India