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 leading global Contract Research Organization (CRO) delivering clinical development, data management, and regulatory support solutions to pharmaceutical, biotechnology, and medical device companies. With a strong focus on data integrity, compliance, and patient safety, Fortrea enables sponsors to accelerate clinical research and bring innovative therapies to market efficiently.
Position Overview
The External Data Reviewer plays a critical role within Clinical Data Management (CDM), supporting the review, validation, and maintenance of external vendor data received from central and local laboratories. This role ensures adherence to departmental SOPs, global standards, and ICH-GCP guidelines to maintain high-quality, compliant, and consistent clinical trial data across projects.
This opportunity is ideal for professionals with clinical data management, external vendor data review, or laboratory data validation experience within pharmaceutical, biotech, or CRO environments.
Key Responsibilities
External Vendor Data Review and Validation
Ensure electronic vendor data includes all protocol-specified parameters.
Verify correct data formatting and accurate population of data fields and patient records.
Review discrepancies generated by study-specific edit checks and manage query resolution processes.
Assist in validation review of electronically transmitted vendor data prior to database loading.
Data Transfer and Specifications Support
Support the Lead Data Manager (LDM) in developing Data Transfer Agreements (DTAs) and Data Transfer Specifications (DTS).
Assist in reviewing External Data edit checks, status reports, and listings.
Identify, document, and escalate data transfer issues, validation concerns, and data point discrepancies.
Laboratory Data Management
Coordinate with Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) to obtain local laboratory normal ranges.
Research and resolve discrepancies related to laboratory normal ranges.
Perform quality control (QC) checks for laboratory reference ranges.
Ensure proper linkage of laboratory normal ranges to patient results within the database.
Stakeholder Communication and Compliance
Support communication with vendors and sponsors regarding data issues under appropriate oversight.
Maintain proper documentation and audit readiness.
Ensure compliance with SOPs, global data standards, and ICH-GCP principles.
Maintain confidentiality of clinical and patient data at all times.
Operational Excellence
Manage multiple priorities in a fast-paced clinical trial environment.
Adjust to shifting priorities and work in flexible shifts as required by business needs.
Educational Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or related discipline
OR
Certification in an allied health profession from an accredited institution
Fortrea may consider equivalent relevant industry experience in lieu of formal education.
Experience Required
Minimum 3 years of experience in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries.
Hands-on experience in clinical data management, external vendor data review, or laboratory data validation preferred.
Working knowledge of ICH-GCP principles and clinical trial processes.
Basic understanding of medical terminology is advantageous.
Key Skills and Competencies
Strong organizational, analytical, and critical-thinking skills.
High attention to detail with focus on data accuracy and integrity.
Strong technical aptitude and proficiency in Microsoft Office tools.
Effective written and verbal communication skills in English.
Ability to handle multiple tasks under demanding timelines.
Ability to maintain strict confidentiality of clinical and sponsor data.
Strong collaboration skills across cross-functional clinical teams.
Work Environment
General office or remote working environment.
Extended periods of computer-based work.
Ability to manage interruptions and frequent priority adjustments.
Willingness to work flexible shifts based on project requirements.
Equal Employment Opportunity
Fortrea is committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment in compliance with applicable laws and regulations.
Discover more Clinical Data Management, Pharmacovigilance, Regulatory Affairs, and CRO career opportunities at ThePharmaDaily.com.
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