Senior Clinical Data Coordinator

Humaneva Group

. Coordinate Endpoint Adjudication Committee (EAC) activities, including case initiation, review, voting, and decision form distribution .

Posted 10/7/2026full-timeRemote • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Data Management, including data review, quality control, and compliance with ICH-GCP and FDA guidelines. Proficient in coordinating adjudication processes and managing clinical trial data to ensure accuracy and protocol adherence.

Highest-signal resume keywords

Clinical Data ManagementICH-GCP ComplianceData Review and Quality ControlEDC Application ExperienceOrganizational and Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Data ReviewData CleaningProtocol ComplianceAdjudication Document PreparationCRF DevelopmentData Management PlansTracking LogsOperational Performance ReportingCase Status MonitoringQuery Resolution

Soft Skills

Strong Organizational SkillsEffective CommunicationTime Management

Tools & Technologies

Data Management SystemsEDC Applications

Industry Keywords

Clinical ResearchPharmacovigilanceFDA GuidelinesStudy ProtocolsSOPs

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Employee employment status