Sr Clinical Data Specialist

4-6 years

Not Disclosed

Bangalore

10 Feb. 4, 2025

Job Description

Job Type: Full Time Education: B.E./BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Clinical Data Specialist – Bangalore, India (sr-clinical-data-specialist-bangalore)

Location: Bangalore, India
Category: Data Management & Data Science
Job ID: 2447289
Company: Fortrea

About Fortrea:

Fortrea is a leading global contract research organization (CRO) with expertise in clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea is committed to transforming drug and medical device development for partners and patients worldwide.

Job Overview:

As a Senior Clinical Data Specialist, you will play a key role in clinical data review, query resolution, and reconciliation, ensuring data quality and integrity. You may also assist in developing Data Management Plans (DMPs), quality guidelines, and system setups, while potentially leading data management activities for smaller projects.

Key Responsibilities:

Review clinical trial data to identify errors, missing information, and inconsistencies based on Global Data Management Plans.
Run diagnostic programs and reconciliation listings to support data review.
Generate, track, and resolve queries to ensure accurate clinical data.
Conduct aggregate reviews to identify patient safety, compliance, and data trends.
Apply quality control (QC) procedures to ensure data meets Fortrea and client standards.
Assist in database design, CRF annotation, and development of data validation checks.
Develop and maintain Data Management and Quality Management Plans.
Serve as a reviewer for project documents such as protocols, CRFs, and DMPs.
Collaborate with project teams to ensure timelines, budgets, and quality expectations are met.
Assist the Lead Data Reviewer/Manager in tracking progress and managing project timelines.
Support internal and external audits and mentor junior team members.

Qualifications & Experience:

Minimum Required:

Bachelor’s degree in Life Sciences, Health Sciences, Information Technology, or related fields (equivalent experience may be accepted).
4–6 years of experience in Clinical Data Management.
Understanding of clinical trials, data management processes, and regulatory standards.
Strong time management, teamwork, and organizational skills.
Experience with data management tools and systems.
Knowledge of medical terminology is preferred.
Good oral and written communication skills.

Preferred Qualifications:

Electronic Data Capture (EDC) experience (2+ years preferred).
Familiarity with Fortrea’s SOPs and structure.

Work Environment:

Flexible work setup: Office-based or remote.
Collaborative, innovation-driven workspace.

Why Join Fortrea?

Fortrea is dedicated to overcoming barriers in clinical trials and delivering life-changing therapies. The company fosters growth, diversity, and inclusion, ensuring all employees thrive in a supportive, dynamic environment.

Join us to make a global impact in clinical research!

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Sr Clinical Data Specialist

Job Description

About Fortrea:

Job Overview:

Key Responsibilities:

Qualifications & Experience:

Work Environment:

Why Join Fortrea?

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