Sr Clinical Data Specialist (EDS)
Location: Bangalore
Category: Data Management & Data Science
Job ID: 254937
Job Overview
The Sr Clinical Data Specialist (EDS) serves as a member of the project team, primarily responsible for clinical data review, query generation/resolution, and reconciliation to ensure delivery of high-quality clinical data according to client specifications, timelines, and productivity targets. The role may also involve assisting in Data Management Plan (DMP) development, system setup, and acting as an operational data management leader on small projects.
Summary of Responsibilities
Review clinical trial data in accordance with Global Data Management Plans, SOPs, and Work Instructions to identify erroneous, missing, incomplete, or implausible data.
Run ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) to support data review.
Generate, resolve, and track queries for problematic data.
Perform aggregate review of data by patient, site, or project to identify trends or inconsistencies requiring further investigation.
Apply quality control procedures to ensure data quality standards (client and Fortrea) are met.
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 and timely clinical data.
Review database design and annotate CRFs/eCRFs per specifications.
Assist in creating data review guidelines consistent with clinical data models and CRF/eCRF conventions.
Support development and testing of system edit/data validation checks, diagnostics, and special listings for data review.
Collaborate with Lead Data Manager or Lead Data Reviewer to build timelines and meet project milestones.
Maintain knowledge of Data Management tools, systems, and processes.
Monitor service and quality to meet specifications in the DMP and budget.
Track budgeted unit overages and assist in Change Order Log process, if applicable.
Perform quality control on data management activities, including study documentation, query generation, and integration.
Support and address client/internal audits, resolving issues promptly.
Mentor and train project staff on project-specific and standardized data management processes.
Perform other duties as assigned by management.
Qualifications (Minimum Required)
University/college degree in Life Sciences, Health Sciences, IT, or related fields preferred.
Relevant education plus experience equivalent to a bachelor’s degree may be considered.
Experience (Minimum Required)
4–6 years of Clinical Data Management experience.
Knowledge of clinical trial processes, data management, clinical operations, biometrics, and supporting systems.
Strong time management and ability to meet project productivity metrics and timelines.
Ability to work collaboratively within a team.
Good organizational, communication, and interpersonal skills.
Knowledge of medical terminology preferred.
Scientific background preferred.
Good oral and written communication skills.
Preferred Qualifications
Familiarity with Fortrea structure and SOPs.
2+ years of Electronic Data Capture (EDC) experience.
Physical Demands / Work Environment
Office-based and/or home-based work environment.
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