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.
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