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Clinical Data Specialist

3-5 years
9 lakh per annum
10 Jan. 31, 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

📌 Clinical Data Specialist | Fortrea – Bengaluru

💼 Company: Fortrea
📍 Location: Bengaluru, India
🕒 Job Type: Full-Time

About Fortrea

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. They provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, operating in around 100 countries. Fortrea aims to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

Position Overview

As a Clinical Data Specialist, you will be responsible for reviewing clinical trial data, generating and resolving queries, and supporting Data Management leads in the delivery of high-quality clinical data within specified timelines. You will also assist with study design, development of Data Management Plans, and data systems setup.

Key Responsibilities

  • Data Review & Query Generation: Review clinical data as per Data Management Plans and raise queries to resolve missing, incomplete, or erroneous data.
  • Collaborative Support: Work with project teams for set-up, maintenance, and closure of data management activities.
  • Special Listings: Run and execute programs like reconciliation discrepancy listings to support data review.
  • Edit Check Validation: Assist in testing edit checks, create dummy data for database and SAS reports testing.
  • Database Locking: Support Database Lock and Unlock activities and help with study status reports for Sponsor meetings.
  • Documentation: Maintain eTMF and handle other data management documentation tasks.
  • Training: Train new staff on project-specific Data Management processes.

Qualifications

🎓 Education:

  • University/College Degree in Life Sciences, Health Sciences, Information Technology, or related fields.

💼 Experience:

  • 3 to 5 years of experience in Data Management, with expertise in clinical data review and query generation.
  • Knowledge of medical terminology is preferred.
  • Experience with clinical data management practices and an understanding of scientific principles is an advantage.

Skills

  • Strong time management skills and ability to meet project deadlines.
  • Excellent oral and written communication abilities.
  • Strong organizational, interpersonal, and teamworking skills.
  • Problem-solving attitude, especially under time pressure and incomplete information.

Preferred Qualifications

  • Knowledge of Fortrea’s operations and SOPs.

Work Environment

  • Office or home-based work.
  • May require overtime and weekend work as needed.
  • Flexibility to work in shifts according to business requirements.

Why Join Fortrea?

Fortrea is looking for passionate individuals who thrive in overcoming challenges within the clinical trials space. By joining their team, you'll contribute to global medical advancements and grow in a collaborative and innovative environment.

How to Apply

Interested candidates can apply online directly on the Fortrea website.