Job Title: Clinical Data Specialist
Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447267
Company Overview:
Fortrea is a global contract research organization (CRO) providing a broad range of clinical development, patient access, and technology solutions across 20+ therapeutic areas. The company operates in around 100 countries, and their goal is to advance drug and device development for clients and patients globally.
Job Overview:
As a Clinical Data Specialist, you will be responsible for conducting clinical data reviews, generating and resolving queries, and assisting with reconciliation activities to ensure the delivery of high-quality clinical data according to client specifications and project timelines. You will support the Data Management lead and contribute to the development of data management plans, data review guidelines, and edit checks.
Key Responsibilities:
Data Management & Review:
Ensure projects are conducted in accordance with protocols, SOPs, and GCP standards.
Assist with clinical trial data review per the Data Management Plan and data review guidelines.
Identify and resolve discrepancies, missing, or incomplete data through query generation and tracking.
Run additional programs like special listings and reconciliation discrepancy listings to support data review.
Database & System Setup:
Assist with setting up data management systems according to project specifications.
Review Edit Check Specifications and Database specifications.
Documentation & Reporting:
Generate data listings for internal reviews and assist with database lock/unlock activities.
Support the creation of dummy data for testing and validating data management tools.
Maintain eTMF and other related documentation as required.
Training & Support:
Train new staff on project-specific data management processes.
Attend project meetings to support the setup, maintenance, and closure of data management activities.
Qualifications:
Education:
University or college degree in life sciences, health sciences, IT, or related fields, or certification in allied health professions.
Fluency in English (written and verbal).
Experience:
3 to 5 years of experience in clinical data management, with knowledge of one or more therapeutic areas.
Strong organizational, communication, and time management skills.
Familiarity with clinical data management practices and the ability to work within team environments.
Skills:
Knowledge of medical terminology is preferred.
Good interpersonal and problem-solving skills, with a constructive attitude when facing challenges.
Preferred Qualifications:
Knowledge of Fortrea's organizational structure and SOPs.
Familiarity with Fortrea's data management systems.
Work Environment:
The position is flexible, allowing for both office and home-based work. You may be required to work overtime or weekends based on business needs.
Equal Opportunity Employer:
Fortrea is committed to diversity and inclusion, offering equal opportunities to all candidates, regardless of their background or identity.
This role offers an exciting opportunity for experienced clinical data professionals to contribute to the development of life-changing therapies. If you're interested, apply or reach out for further details!
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