External Data Reviewer – Clinical Data Management
Location: Bangalore / Hyderabad, India
Employment Type: Full-Time
Application Deadline: March 23, 2026
Experience Required: Minimum 3+ years in clinical data management, external/vendor data handling, or clinical research
Job Overview
We are looking for an experienced External Data Reviewer to support clinical data management activities focused on vendor and laboratory data integration. This role plays a critical part in ensuring data integrity, consistency, and compliance with global standards across clinical trials.
The ideal candidate will work closely with Lead Data Managers (LDMs), clinical teams, and external vendors to review, validate, and manage external data in accordance with study protocols, SOPs, and ICH-GCP guidelines.
Key Responsibilities
Review and validate external vendor data to ensure accuracy, completeness, and alignment with protocol-specified parameters
Ensure proper formatting and correct mapping of data into clinical databases and patient records
Support the development and maintenance of Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS)
Identify and resolve data discrepancies through edit checks and query management processes
Assist in validation of electronically transferred data for selected patient samples prior to database loading
Review external data listings, status reports, and edit check outputs to ensure data quality
Collaborate with clinical teams (CTMs, CRAs) to collect and verify local laboratory normal ranges across study sites
Perform quality control checks for lab data and ensure proper linkage to patient records within the system
Communicate with vendors and internal stakeholders to resolve data transfer issues and validation discrepancies
Maintain accurate documentation and ensure compliance with SOPs, regulatory guidelines, and global standards
Required Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or a related field
Fluency in English (written and verbal)
Strong understanding of clinical data workflows and external data management processes
Preferred Skills and Experience
Minimum 3+ years of experience in clinical trials, pharmaceutical, biotechnology, or CRO environments
Basic knowledge of medical terminology and clinical research processes
Familiarity with external data systems, clinical databases, and data validation processes
Understanding of ICH-GCP guidelines and regulatory compliance standards
Proficiency in Microsoft Office tools and data handling systems
Key Competencies
Strong analytical, problem-solving, and critical-thinking abilities
Excellent organizational and time management skills
Ability to manage multiple priorities in a fast-paced, deadline-driven environment
Effective communication and stakeholder management skills
High attention to detail with a focus on data accuracy and confidentiality
Work Environment and Expectations
Office-based or remote work setup with flexibility based on business needs
Ability to work in flexible or shift-based schedules
High-interaction role requiring coordination with global teams and external vendors
Why Apply
This position offers an opportunity to work on global clinical trials, gain expertise in external data management, and contribute to high-quality, compliant clinical data processes in a dynamic and collaborative environment.
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