Senior Clinical Data Coordinator

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee the activities of the Endpoint Adjudication Committee (EAC), including the initiation of cases, case reviews, voting processes, and distribution of decision forms.

• Evaluate and reconcile clinical trial data to ensure it meets standards of completeness, accuracy, and adherence to protocols.

• Manage adjudication case packets, ensuring timely collection and submission of source documents.

• Generate, monitor, and address queries related to clinical data and adjudication.

• Prepare and maintain necessary adjudication documents, forms, reports, listings, and study materials.

• Develop and sustain Case Report Forms (CRFs), data management plans, tracking logs, and comprehensive study documentation.

• Conduct data reviews, quality control checks, and data cleaning processes to maintain data integrity.

• Monitor the status of cases, study metrics, and produce operational performance reports.

• Act as a liaison among sponsors, sites, committee members, vendors, and external stakeholders.

• Coordinate data transfers and exchanges with vendors, laboratories, and imaging review partners.

• Assist in the development and implementation of EAC processes, workflows, and operational tools.

• Ensure compliance with ICH-GCP, regulatory standards, study protocols, and Standard Operating Procedures (SOPs).

• Engage in study meetings, training activities, and collaborations across functions.

⛳️ Requirements

• A minimum of a Master's/Pharm D degree in any discipline is required; a background in Life Sciences is preferred.

• A minimum of 4–6 years of experience in Clinical Data Management or related fields such as Pharmacovigilance, Clinical Research Coordination, or within pharmaceutical or medical device companies.

• Excellent organizational, communication, and time management abilities.

• Familiarity with FDA, ICH, and GCP guidelines as they pertain to clinical studies and data management.

• Experience with one or more Data Management/Data Collection Systems/Vendors, with a preference for familiarity with EDC applications.

• Capability to operate effectively in a dynamic, fast-paced environment.

🏝️ Benefits

• Employee employment status