Clinical Data Specialist

3-5 years

Not Disclosed

Bangalore

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: BE/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

Position: Clinical Data Specialist
Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447267

Job Overview

Fortrea is seeking a Clinical Data Specialist to play a key role in clinical data review, query generation, and resolution activities. The Specialist will support the Data Management lead in ensuring high-quality clinical data delivery according to client specifications and project timelines. This role also involves contributing to the development of Data Management Plans, data review guidelines, and the setup of data management systems.

Key Responsibilities

Clinical Data Review:
- Conduct data review as per Data Management Plans and Data Review Guidelines.
- Raise queries to resolve erroneous, missing, or incomplete data.
- Generate, resolve, and track queries related to data quality.
Project Support & Documentation:
- Support the setup, maintenance, and closure of Data Management aspects of the project.
- Assist with the creation of dummy data for testing database designs, edit checks, and SAS reports.
- Maintain eTMF and other data management documentation.
- Generate and QC data listings for internal reviews.
Database Management & Reporting:
- Assist with Database Lock and Unlock activities.
- Run status reports and assist with Sponsor meetings and requests.
Team Collaboration & Training:
- Collaborate with project team members and attend meetings as needed.
- Support training for new staff on project-specific data management processes.
Other Duties:
- Perform additional tasks as assigned.

Qualifications

Minimum Requirements:
- Degree in Life Sciences, Health Sciences, Information Technology, or a related field.
- Fluent in written and spoken English.
Experience:
- 3 to 5 years of experience in data management, with knowledge of one or more therapeutic areas.
- Demonstrated ability to meet project timelines and productivity metrics.
- Knowledge of clinical data management practices and medical terminology.
Preferred Qualifications:
- Knowledge of Fortrea's structure and standard operating procedures.

Company Overview

Fortrea is a leading global contract research organization (CRO) that collaborates with pharmaceutical, biotechnology, and medical device companies to accelerate drug and device development. With a focus on clinical trials, Fortrea operates in over 100 countries, striving to bring life-changing therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate discrimination or harassment and encourage all qualified candidates to apply.

Accommodation

Fortrea offers reasonable accommodations for applicants during the hiring process. For accommodation requests, please contact taaccommodationsrequest@fortrea.com.

Slug: clinical-data-specialist

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Clinical Data Specialist

Job Description

Job Overview

Key Responsibilities

Qualifications

Company Overview

Equal Opportunity Employer Statement

Accommodation

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