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Sr Clinical Data Specialist(Eds)

4-6 years
Not Disclosed
10 Oct. 6, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr Clinical Data Specialist (EDS)

Job ID: 254937
Category: Data Management & Data Science
Location: Bangalore
Work Environment: Office and/or home-based


Role Summary

Serve as a project team member responsible for clinical data review, query generation/resolution, and reconciliation to ensure delivery of high-quality clinical data in line with client specifications, project timelines, and productivity targets. Potential involvement in Data Management Plan development and operational leadership as a Lead Data Reviewer on small projects.


Primary Responsibilities

  • Review clinical trial data per Global Data Management Plans and standardized SOPs to identify errors, missing, incomplete, or implausible data.

  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) to support data review.

  • Generate, resolve, and track queries related to data issues.

  • Perform aggregate reviews of clinical data by patient, site, or project to detect trends and inconsistencies requiring investigation.

  • Apply quality control checks to ensure data meets client and Fortrea standards.

  • Review project documents such as protocols, CRFs/eCRFs, and Data Management Plans.

  • Assist in the development of Data Management Plans and Quality Management Plans for accurate, timely, and consistent data delivery.

  • Support database design review and annotate CRFs/eCRFs as per specifications.

  • Assist in developing and testing data management system edits, validations, and special listings used in data review and discrepancy management.

  • Collaborate with Lead Data Manager or Lead Data Reviewer to build timelines and meet project milestones.

  • Monitor and report budget overages; assist with Change Order Log processes if applicable.

  • Perform quality control on data management activities including study documentation, query generation, and integration.

  • Support client or internal audits and resolve issues promptly.

  • Mentor and train project staff on project-specific and standardized data management processes.

  • Perform other duties as assigned.


Minimum Required Qualifications

  • University/college degree in life sciences, health sciences, information technology, or related subjects preferred.

  • Relevant work experience may be accepted in lieu of a bachelor’s degree.


Minimum Required Experience

  • 4–6 years in Clinical Data Management.

  • Knowledge of clinical trial processes, data management, clinical operations, biometrics, and supporting system applications.

  • Strong time management and ability to meet project productivity metrics and timelines.

  • Ability to collaborate in a team environment.

  • Good organizational, communication, and interpersonal skills.

  • Basic knowledge of medical terminology and scientific background preferred.


Preferred Qualifications

  • Thorough knowledge of Fortrea organization structure and SOPs.

  • 2+ years of Electronic Data Capture (EDC) experience.


Physical Demands / Work Environment

  • Office and/or home-based work environment.