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Clinical Data Specialist

2+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Opportunity: Clinical Data Reviewer

Company: Fortrea
Location: [Insert Location]
Job Type: [Insert Job Type]

Company Overview

Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development experience. We offer pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Job Summary

As a member of the project team, the Clinical Data Reviewer will be primarily responsible for conducting clinical data reviews, generating and resolving queries, and performing reconciliation activities. This role supports the Data Management lead in delivering clinical data that meets client quality and integrity specifications, project timelines, and productivity targets. You will also assist in developing the project Data Management Plan, including data review guidelines and eCRF specifications.

Key Responsibilities

  • Ensure all allocated projects comply with relevant protocols, global SOPs, and GCP standards.
  • Demonstrate the ability to follow study timelines for timely deliverables.
  • Assist in reviewing clinical trial data as per Data Management Plans and raise queries to address erroneous or missing data.
  • Execute additional programs (e.g., reconciliation discrepancy listings) to support data review activities.
  • Generate, resolve, and track queries to address problematic data identified during aggregate reviews.
  • Collaborate with project team members to support the setup, maintenance, and closure of Data Management aspects.
  • Generate and perform quality control on data listings for internal review.
  • Assist in creating dummy data to test edit checks and database functionality.
  • Review Edit Check Specifications and Database specifications.
  • Perform data management-related administrative tasks, including maintaining eTMF as required.
  • Run study status reports in preparation for Sponsor meetings and specific Sponsor requests.
  • Assist with Database Lock and Unlock activities.
  • Support the training of new staff on project-specific Data Management processes.
  • Perform any other duties as assigned.

Why Join Fortrea?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that fosters personal growth and enables you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.


Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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