Job Title: External Data Reviewer
Company: Fortrea
Location: Bangalore, India
Department: Clinical Data Management
Job Type: Full-Time
Job ID: 26721
Experience Required: Minimum 3 Years in Clinical Data Management or Clinical Research
About Fortrea
Fortrea is a leading global contract research organization (CRO) providing clinical development, regulatory, and pharmacovigilance services to pharmaceutical, biotechnology, and medical device companies worldwide. With strong expertise in clinical trials and data management, Fortrea supports sponsors across the entire drug development lifecycle while maintaining the highest standards of data integrity, regulatory compliance, and scientific quality.
Role Overview
The External Data Reviewer supports clinical data management activities by reviewing and validating external vendor data received from laboratories and other external sources. The role ensures that vendor data is accurate, complete, and aligned with protocol specifications before integration into clinical trial databases. This position plays a key role in maintaining data quality, resolving discrepancies, and ensuring compliance with global clinical research standards and Good Clinical Practice (GCP) guidelines.
Key Responsibilities
External Vendor Data Review
Review electronic vendor data to ensure all protocol-specified parameters are included and formatted correctly.
Verify that external data populates accurately into designated fields and patient records within the clinical database.
Maintain data integrity and consistency across clinical projects in accordance with departmental SOPs and global data standards.
Data Transfer and Integration Support
Assist the Lead Data Manager (LDM) in developing Data Transfer Agreements (DTA) and Data Transfer Specifications for vendor data transfers.
Support validation checks for electronically transmitted vendor data before database loading.
Ensure accurate mapping and integration of external data into study databases.
Data Discrepancy Management
Review discrepancies identified through study-specific edit checks related to external vendor data.
Perform query management activities to investigate and resolve data inconsistencies.
Maintain accurate documentation of discrepancy resolution activities.
External Data Quality Control
Assist in reviewing external data edit checks, status reports, and data listings to ensure quality standards are maintained.
Conduct quality control processes to verify the accuracy and completeness of vendor data.
Laboratory Data Management
Collaborate with clinical teams such as Clinical Trial Managers (CTM) and Clinical Research Associates (CRA) to collect local laboratory normal ranges for clinical sites.
Investigate discrepancies in laboratory reference ranges and maintain proper documentation.
Enter laboratory normal ranges into the database and perform quality checks to ensure accurate association with patient results.
Vendor Communication and Issue Resolution
Support communication with vendors and clients regarding issues related to data transfers, validation processes, and data point discrepancies.
Assist senior team members in coordinating resolutions to data-related issues affecting clinical trial datasets.
Educational Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or a related discipline.
Certifications in allied health or clinical research fields may also be considered.
Experience Requirements
Minimum 3 years of experience in clinical data management, clinical trials, pharmaceutical, biotechnology, or medical device industries.
Experience working with external vendor data in clinical trials is preferred.
Required Skills and Competencies
Basic understanding of medical and clinical research terminology.
Strong knowledge of clinical data management processes and data validation practices.
Familiarity with ICH-GCP guidelines and clinical trial regulatory standards.
Strong organizational and analytical skills with attention to detail.
Ability to manage multiple priorities and work efficiently under tight deadlines.
Excellent written and verbal communication skills for collaboration with internal teams and external vendors.
Technical Skills
Proficiency in Microsoft Office tools including Word, Excel, and PowerPoint.
Strong technical aptitude and ability to work with clinical databases and data management systems.
Experience reviewing and validating external clinical data.
Work Environment
Office-based or remote working environment with extended computer usage.
Ability to manage multiple tasks and priorities with frequent adjustments based on project requirements.
Flexibility to work in different shifts depending on global project needs.
Job Location
Bangalore, India.
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