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Clinical Data Specialist(Eds)

3-5 years
Not Disclosed
10 Feb. 19, 2025
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 Title: Clinical Data Specialist (EDS)

Location: Bangalore
Category: Data Management & Data Science
Job ID: 25217


Company Overview:

Fortrea is a leading global contract research organization (CRO), committed to delivering clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in nearly 100 countries, Fortrea is driving the transformation of drug and device development globally.


Job Overview:

The Clinical Data Specialist (EDS) plays a key role in clinical data review, query generation and resolution, and reconciliation activities. The goal is to support the Data Management lead in delivering clinical data that meets client specifications, quality, and integrity standards within the project timelines.


Key Responsibilities:

  • Data Management & Review:

    • Ensure compliance with protocols, SOPs, and GCPs.

    • Review clinical trial data according to the Data Management Plan and resolve any issues (e.g., erroneous, incomplete, or missing data).

    • Generate, track, and resolve queries related to problematic data.

    • Execute programs such as reconciliation discrepancy listings to assist in data review.

  • System Setup & Support:

    • Assist in setting up data management systems based on project requirements.

    • Test edit checks, database screen designs, and reports using dummy data.

  • Documentation & Reporting:

    • Post and maintain relevant documentation in eTMF.

    • Prepare study status reports for Sponsor meetings.

    • Assist in Database Lock and Unlock activities.

  • Collaboration & Training:

    • Work closely with other project team members to ensure smooth setup and closure of data management activities.

    • Support the training of new staff on project-specific data management processes.


Qualifications:

  • Education:

    • A university/college degree in life sciences, health sciences, information technology, or related fields, or a certification in allied health professions.

    • Fluent in English (both written and verbal).

  • Experience:

    • 3 to 5 years of relevant experience in data management, with knowledge of at least one therapeutic area.

    • Strong organizational skills and experience in meeting project timelines and productivity targets.

  • Skills:

    • Knowledge of medical terminology is preferred.

    • Ability to collaborate within a team environment and manage multiple tasks.


Preferred Qualifications:

  • Familiarity with Fortrea’s standard operating procedures and organizational structure.

  • A scientific background or knowledge of clinical data management practices.


Work Environment:

  • Flexible work environment (office or home-based).

  • May require overtime or weekend work based on project needs.

  • Willingness to work flexible shifts if needed.


Equal Opportunity Employer:

Fortrea is committed to fostering a diverse and inclusive workforce. The company does not tolerate any form of harassment or discrimination and makes employment decisions based on business needs and individual qualifications.


This role presents a unique opportunity for professionals with clinical data management experience to work in a dynamic, global setting. If you're interested, consider applying for the position to join Fortrea’s mission to revolutionize the clinical trials process.