External Data Reviewer | Hyderabad, India
Company: Fortrea
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Job ID: 26721
Work Model: Office-Based / Remote (as per business requirement)
About Fortrea
Fortrea is a global Contract Research Organization (CRO) specializing in clinical development, data management, and regulatory services for pharmaceutical, biotechnology, and medical device companies. With a strong focus on data integrity and compliance, Fortrea supports sponsors in delivering high-quality clinical research outcomes aligned with global regulatory standards.
Job Overview
The External Data Reviewer is responsible for reviewing, validating, and maintaining external vendor data received from central laboratories or local laboratories within clinical trials. This role supports the Lead Data Manager (LDM) in ensuring adherence to Standard Operating Procedures (SOPs), ICH-GCP guidelines, and global data standards to maintain consistency, accuracy, and regulatory compliance across projects.
This position is critical in safeguarding clinical trial data integrity and supporting efficient database management processes.
Key Responsibilities
External Vendor Data Review
Verify that electronic vendor data includes all protocol-specified parameters.
Ensure accurate formatting and correct mapping of data to patient records and database fields.
Review discrepancies generated through study-specific edit checks and manage the query resolution process.
Support validation review of electronically transmitted vendor data prior to database loading.
Data Transfer and Specifications
Assist the Lead Data Manager (LDM) in developing Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS).
Review external data edit checks, status reports, and data listings.
Identify and escalate issues related to data transfers, validation errors, and data inconsistencies.
Laboratory Data Management
Collaborate with Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) to obtain local laboratory normal ranges.
Investigate and resolve discrepancies in laboratory reference ranges.
Perform data entry and quality control (QC) for laboratory normal ranges.
Ensure correct linkage of laboratory reference ranges to patient results within the clinical database.
Compliance and Documentation
Ensure adherence to SOPs, global data standards, and ICH-GCP principles.
Maintain proper documentation and audit readiness.
Ensure strict confidentiality of clinical and sponsor data.
Support vendor and sponsor communications under appropriate oversight.
Operational Support
Manage multiple priorities in a fast-paced clinical research environment.
Adapt to frequent priority changes and work flexible shifts as required.
Educational Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or related field
OR
Certification in an allied health profession from an accredited institution
Equivalent relevant industry experience may be considered in lieu of formal educational qualifications.
Experience Required
Minimum 3 years of experience in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries.
Prior experience in Clinical Data Management, External Vendor Data Review, or Laboratory Data Validation preferred.
Working knowledge of ICH-GCP guidelines and clinical trial data standards.
Basic understanding of medical terminology is advantageous.
Key Skills and Competencies
Strong analytical and critical-thinking abilities.
High attention to detail and data accuracy.
Excellent written and verbal communication skills in English.
Strong organizational and planning skills.
Ability to manage multiple tasks under demanding timelines.
Proficiency in Microsoft Office applications.
Strong technical aptitude with clinical databases and data systems.
Commitment to maintaining data confidentiality and regulatory compliance.
Work Environment
General office or remote working environment.
Extended periods working at a computer.
Frequent task prioritization and interruptions.
Flexibility to work in shifts based on business requirements.
Equal Opportunity Statement
Fortrea is committed to equal employment opportunity and fostering a diverse and inclusive workplace. All qualified candidates will be considered in accordance with applicable employment laws and regulations.
Explore the latest Clinical Data Management, Pharmacovigilance, Regulatory Affairs, and CRO career opportunities at ThePharmaDaily.com.
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