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Sr Clinical Data Specialist

4-6 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: 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

๐Ÿ“Œ Sr Clinical Data Specialist – Bangalore | Fortrea

๐Ÿ’ผ Company: Fortrea
๐Ÿ“ Location: Bangalore
๐Ÿ•’ Category: Data Management & Data Science
๐Ÿ“Œ Job ID: 2447289

About Fortrea

Fortrea is a global leader in Contract Research Organization (CRO) services, with extensive expertise in clinical development and a commitment to scientific rigor. Operating across 100 countries, Fortrea serves pharmaceutical, biotechnology, and medical device customers, delivering a broad range of services across 20+ therapeutic areas.

Position Overview

The Sr Clinical Data Specialist will serve as a key member of the project team, primarily responsible for clinical data review, query generation, resolution, and reconciliation. The role involves working with the Lead Data Reviewer and Data Management team to ensure the delivery of high-quality clinical data, meeting client specifications, and adhering to project timelines and budgets.

Key Responsibilities

โœ” Clinical Data Review: Conduct data review according to the Data Management Plan (DMP), identifying erroneous or incomplete data and ensuring adherence to quality control standards.
โœ” Query Management: Generate, resolve, and track queries to address problematic data identified during the review process.
โœ” Data Trend Analysis: Perform aggregate reviews of clinical data to detect trends (e.g., safety, compliance) and identify inconsistencies requiring further investigation.
โœ” Document Review: Review clinical trial documents such as protocols, CRFs (or eCRFs), and Data Management Plans to ensure data accuracy.
โœ” Data Management Systems: Assist in setting up and maintaining data management systems, including validation checks, edit checks, and special listings.
โœ” Project Leadership: Potential to serve as the operational data management leader on smaller projects, managing timelines and ensuring timely delivery of high-quality clinical data.
โœ” Mentoring: Provide guidance and mentorship to project staff, supporting them in understanding and applying standardized data management processes.
โœ” Audit Support: Participate in internal and client audits, resolving issues in a timely manner.

Qualifications

๐ŸŽ“ Education:

  • University or college degree in life sciences, health sciences, information technology, or related fields preferred.
  • Equivalent experience will be considered in lieu of a degree.

๐Ÿ’ผ Experience:

  • 4 to 6 years of experience in Clinical Data Management.
  • Familiarity with clinical trial processes, biometrics, and data management systems.

Skills

  • Strong organizational and time management skills.
  • Excellent communication and interpersonal abilities.
  • Ability to work collaboratively in a team environment.

Preferred Qualifications

  • Experience with Electronic Data Capture (EDC) systems.
  • Knowledge of Fortrea’s organizational structure and SOPs.

Why Join Fortrea?

At Fortrea, we are dedicated to transforming the clinical trials process and making a significant impact on global healthcare. Join our team of innovative problem-solvers, and experience a collaborative workspace that fosters personal growth.

For more information, visit www.fortrea.com.

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