Senior Clinical Data Coordinator

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.
• Strong 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.