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Sr Clinical Data Specialist

4-6 years
Not Disclosed
10 Sept. 12, 2025
Job Description
Job Type: Full Time Hybrid 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: Senior Clinical Data Specialist
Location: Bangalore
Category: Data Management & Data Science
Job ID: 254039


Job Overview

The Senior Clinical Data Specialist is a key member of the project team responsible for clinical data review, query generation/resolution, and reconciliation. The role ensures delivery of high-quality clinical data according to client standards, project timelines, and productivity targets. The position may assist in developing project Data Management Plans (DMP), system setup, and act as operational data management lead for small projects.


Key Responsibilities

Data Review & Quality Control

  • Review clinical trial data per Data Management Plans (DMPs) and applicable SOPs to identify errors, missing data, or inconsistencies.

  • Generate, resolve, and track queries for problematic data.

  • Perform aggregate review of clinical data by patient, site, or project to identify trends or inconsistencies.

  • Apply quality control procedures to ensure client and Fortrea data quality standards are met.

Documentation & System Support

  • Assist in the review and annotation of CRFs/eCRFs according to specifications.

  • Support the development of data review guidelines consistent with clinical data models and CRF completion conventions.

  • Assist in developing and testing data management system edit/validation checks and special listings for data review and discrepancy management.

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

Project Coordination

  • Collaborate with Lead Data Managers/Lead Data Reviewers to build timelines and meet contracted milestones.

  • Inform Lead Data Reviewer of budget overages and assist in Change Order Log process, if applicable.

  • Support client or internal audits and address findings promptly.

Mentorship & Team Support

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

  • Perform other duties as assigned by management.


Qualifications

Minimum Requirements

  • University/college degree (Life Sciences, Health Sciences, IT, or related preferred). Equivalent work experience considered.

  • 4–6 years of Clinical Data Management experience.

  • Basic knowledge of clinical trial processes, DM, clinical operations, biometrics, and supporting system applications.

  • Knowledge of medical terminology preferred.

  • Strong organizational, time management, communication, and interpersonal skills.

  • Ability to work effectively in a team environment.

Preferred Qualifications

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

  • Thorough knowledge of Fortrea organization structure and SOPs.

  • Scientific background or knowledge of science preferred.


Work Environment

  • Office and/or home-based work environment.

  • Flexibility to adapt to project timelines and requirements.


Key Competencies

  • Clinical data review and query management

  • Quality control and compliance

  • Documentation and system annotation

  • Mentorship and team support

  • Cross-functional collaboration