PHARMAFull-time
Clinical Data Specialist
BANGALORE (IN)REMOTEPOSTED: 9/3/2026
PHARMAFull-time
HIRING ORGANIZATIONFORTREAContract Research Organization (CRO) / Biosciences / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Serve as a member of the clinical project team with primary responsibility for clinical data review, query generation and resolution, and reconciliation activities.
Support the Data Management Lead in delivering clinical data that meets client quality, integrity, project timeline and productivity requirements.
Review clinical trial data and identify erroneous, missing or incomplete information requiring clarification.
Contribute to project data-management activities from study setup through maintenance, database lock and project closure.
Assist with development of Data Management Plans, data-review guidelines, edit-check specifications and eCRF specifications.
May contribute to the setup of clinical data-management systems according to project requirements.
Clinical Data Review & Query Management
Review clinical trial data according to approved Data Management Plans and Data Review Guidelines.
Conduct detailed data-review activities to identify missing, erroneous, inconsistent or incomplete clinical data.
Generate data queries to obtain clarification and resolution for problematic clinical information.
Resolve and track queries generated during aggregate and ongoing clinical data-review activities.
Monitor outstanding queries and support timely resolution to maintain data quality and project timelines.
Perform reconciliation activities to identify and address data discrepancies.
Support the production of clean, accurate and complete clinical trial datasets.
Data Management Planning & Study Setup
Assist in the development of project Data Management Plans.
Support the preparation and maintenance of data-review guidelines.
Assist with review and development of edit-check specifications.
Support eCRF specification activities.
Review Edit Check Specifications and Database Specifications.
Contribute to the setup of data-management systems based on study and project requirements.
May assist with or provide inputs related to study design.
May provide suggestions regarding study timelines when appropriate.
Data Listings, Programs & Quality Control
Run and execute additional programs supporting clinical data review.
Generate and review special data listings.
Run reconciliation discrepancy listings.
Execute programs used to identify potential data issues during clinical data review.
Generate data listings for internal review.
Perform quality-control checks on data listings before use or delivery.
Support internal review processes through accurate and timely production of study data outputs.
Database & Edit Check Testing
Assist with or create dummy data for testing edit checks.
Use dummy data to test database screen design and system functionality.
Support testing of edit-check logic and specifications.
Assist with or create dummy data to test SAS reports.
Support testing of SAS-generated data listings.
Identify potential issues affecting data validation, database functionality or reporting outputs.
Project Team & Cross-Functional Collaboration
Interact with project team members throughout data-management setup, maintenance and closure activities.
Attend project meetings as required.
Collaborate with peers and other functional team members to support project deliverables.
Support Data Management Leads in achieving clinical data quality, integrity and timeline objectives.
Participate in project-specific discussions and activities related to study progress.
Maintain effective communication with internal stakeholders.
Study Status & Sponsor Support
Run study-status reports in preparation for Sponsor meetings.
Generate reports to support specific Sponsor requests.
Support accurate tracking and communication of data-management progress.
Contribute to timely delivery of project information required by Sponsors and internal project teams.
Database Lock & Study Closure
Assist with Database Lock activities.
Support Database Unlock activities when required.
Participate in data-management tasks associated with study maintenance and closure.
Ensure assigned data-management activities are completed according to project requirements and timelines.
Support controlled completion of clinical data-management deliverables before and during database lock.
Documentation & Administrative Responsibilities
Complete post-data-management documentation activities as requested.
Perform data-management-related administrative tasks.
Maintain electronic Trial Master File (eTMF) documentation when required.
Ensure allocated project activities are documented appropriately according to project and organizational requirements.
Perform additional assigned duties in support of project objectives.
Regulatory, Quality & Compliance Standards
Carry out allocated project activities in accordance with applicable clinical study protocols.
Follow global harmonized Standard Operating Procedures (SOPs).
Comply with specified Good Clinical Practice (GCP) standards.
Maintain clinical data quality and integrity according to client specifications.
Follow approved Data Management Plans and project-specific data-review requirements.
Support controlled and compliant clinical data-management processes.
Training & Team Support
Support training of new staff on project-specific Clinical Data Management processes.
Share project knowledge and operational requirements with newly assigned team members.
Contribute to effective team integration and consistent application of project data-management processes.
Qualifications
University or college degree in Life Sciences, Health Sciences, Information Technology or a related discipline.
Alternatively, certification in an allied health profession from an appropriate accredited institution may be considered.
Fluency in English is required, including both written and verbal communication.
Experience Requirements
Requires 3 to 5 years of relevant Clinical Data Management experience with increasing responsibility.
Requires knowledge or experience in one or more therapeutic areas.
Requires knowledge of effective Clinical Data Management practices.
Medical terminology knowledge is preferred.
A scientific background or knowledge of science is preferred.
Requires demonstrated ability to manage time and meet project productivity metrics.
Requires the ability to work according to project timelines and deliver on-time outputs.
Professional Competencies
Strong time-management skills.
Ability to adhere to project productivity metrics and deadlines.
Good written and verbal communication skills.
Ability to work effectively in a team environment.
Strong collaboration and peer-working capabilities.
Good organizational and interpersonal skills.
Constructive problem-solving approach.
Ability to remain deadline-focused when managing incomplete information, unexpected events and changing project requirements.
Preferred Qualifications
Knowledge of Fortrea and its organizational structure.
Knowledge of Fortrea Standard Operating Procedures.
Work Environment
Remote role associated with the Bangalore location.
Work may be performed in an office and/or home-based environment.
May require overtime depending on project and business requirements.
May require weekend work when needed.
Candidates should be willing to work flexible shifts based on business requirements.
REQUIRED VERIFIED SKILLS
Clinical Data Management
Clinical Data Review
Data Query Generation
Query Resolution
Data Reconciliation
Data Management Plans
Data Review Guidelines
Edit Check Specifications
eCRF Specifications
Clinical Trial Data
Data Listings
Reconciliation Listings
Quality Control
Database Testing
Edit Check Testing
Dummy Data Testing
SAS Reports
SAS Data Listings
Database Specifications
Study Status Reports
Sponsor Reporting
Database Lock
Database Unlock
eTMF
Clinical Study Protocols
SOPs
GCP
Clinical Data Quality
Data Integrity
Therapeutic Area Knowledge
English Communication
Time Management
Project Productivity Metrics
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Salary information is not disclosed in the provided official job posting. Compensation for this experience level is likely to depend on years of Clinical Data Management experience, therapeutic-area exposure, technical expertise in clinical data review and database processes, and the employer's location and compensation structure. Candidates should confirm the fixed salary, performance-related compensation, health benefits, insurance, retirement benefits, leave policies, remote-work support and any additional total-rewards components directly with Fortrea during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Fortrea is a global contract research organization (CRO) providing comprehensive clinical development, patient access, and laboratory services. Spun off from Labcorp in 2023, Fortrea partners with pharmaceutical, biotech, and medical device companies to accelerate the development and commercialization of new therapies. They offer a full suite of services across the entire drug development lifecycle.
TEAM SIZE: 19,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Biosciences / Healthcare
EXPECTED CAREER ROADMAP
This Clinical Data Specialist role offers a progression pathway within Clinical Data Management and broader clinical research operations. With additional experience, professionals can advance toward Senior Clinical Data Specialist, Clinical Data Manager, Lead Clinical Data Manager, Project Data Manager or Clinical Data Management leadership roles. Experience across data review, query management, reconciliation, eCRF specifications, edit checks, database testing and database lock activities can build strong end-to-end clinical data-management expertise. Exposure to therapeutic areas, Sponsor interactions and cross-functional clinical project teams can also create opportunities in clinical systems, data standards, data quality, clinical operations and project leadership. Candidates who develop advanced leadership, stakeholder-management and technical data-management capabilities may progress into global or regional data-management strategy and operational leadership positions.
APPLICATION ADVISORY
Tailor your resume toward end-to-end Clinical Data Management responsibilities and clearly highlight experience with clinical data review, query generation and resolution, reconciliation, data listings, edit checks, eCRFs and database lock activities. Mention therapeutic areas and clinical study phases you have supported where applicable. Quantify relevant experience by describing study volume, query-management responsibilities, database-testing activities or timelines achieved. Review GCP principles, clinical data-management workflows, protocol interpretation and common data discrepancies before interviews. Be prepared to explain how you identify and resolve inconsistent or missing clinical data, manage competing deadlines and collaborate with Data Management Leads and cross-functional project teams. If you have experience with SAS listings, eTMF, database testing or clinical data-management systems, clearly describe your practical contribution and level of responsibility.
RECOMMENDED TRAINING
1/5
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