Senior Clinical Data Specialist
Location: Bangalore, India
Category: Data Management & Data Science
Job ID: 255825
Employment Type: Full-Time
Job Overview
The Senior Clinical Data Specialist is responsible for end-to-end clinical data review, query management, reconciliation, and data quality oversight across assigned clinical studies. This role ensures the delivery of high-quality, accurate, and consistent clinical data in alignment with client expectations, regulatory standards, and project timelines.
Candidates may also contribute to Data Management Plan development, data review guidelines, eCRF annotation, and database setup activities. On smaller projects, this role may serve as an operational data management lead, coordinating technical oversight and data delivery processes.
Key Responsibilities
Review clinical trial data according to Data Management Plans (DMPs), SOPs, and global data review processes to identify incomplete, inconsistent, or implausible data.
Execute diagnostic listings, discrepancy listings, and supporting programs for effective data review.
Generate, resolve, and track data queries to ensure data accuracy and ongoing data cleaning compliance.
Perform aggregate data assessments across patient, site, and study levels to identify trends, compliance issues, and discrepancies that require investigation.
Apply quality control checks to ensure data meets internal and sponsor quality standards.
Review project documents including protocols, CRFs/eCRFs, eDiary data, and DMPs.
Support the development of Data Management Plans, Quality Management Plans, and data review guidelines.
Assist in designing and reviewing database structures, CRF annotations, edit checks, validation checks, and listings needed for discrepancy management.
Collaborate with Lead Data Manager or Lead Data Reviewer to build timelines, ensure milestone alignment, and support cross-functional communication.
Ensure adherence to project scope, timelines, and budget, raising potential overages when necessary.
Participate in quality audits, address findings, and support CAPA activities.
Mentor or coach project team members on data management standards and study-specific processes.
Perform additional data management duties as assigned by leadership.
Minimum Qualifications
Bachelor’s or Master’s degree in Life Sciences, Health Sciences, Information Technology, or related fields.
Equivalent education and relevant experience may be considered in lieu of a formal degree.
Experience Requirements
4 to 6 years of experience in Clinical Data Management (mandatory).
Working knowledge of clinical trial processes, data management workflows, clinical operations, and biometrics.
Familiarity with clinical data systems and tools.
Strong time-management skills with the ability to meet productivity metrics and strict timelines.
Effective communication, interpersonal skills, and team collaboration abilities.
Knowledge of medical terminology and scientific concepts is preferred.
Preferred Qualifications
In-depth understanding of Fortrea’s operational structure and SOPs.
2+ years of hands-on experience with Electronic Data Capture (EDC) systems.
Strong organizational skills, analytical mindset, and attention to detail.
Experience supporting audits, documentation reviews, and quality processes.
Work Environment
Office-based or remote/home-based work environment.
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