Sr Clinical Data Specialist

4-6 years

Not Disclosed

Bangalore

10 Feb. 13, 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

Sr Clinical Data Specialist

Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447289

Description:

Fortrea, a leading global contract research organization (CRO), is dedicated to scientific rigor and has decades of clinical development experience. The company provides pharmaceutical, biotechnology, and medical device clients with clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is revolutionizing drug and device development worldwide.

Job Overview:

The Sr Clinical Data Specialist will be responsible for clinical data review, query resolution, and reconciliation to ensure data quality and integrity. The role involves contributing to the development of project Data Management Plans, setting up data management systems, and potentially leading data management activities on small projects.

Summary of Responsibilities:

Review clinical trial data according to Data Management Plans and standardized processes.
Run diagnostics, special listings, and reconciliation discrepancy reports.
Generate, resolve, and track queries to address data inconsistencies.
Perform aggregate reviews of clinical data to identify trends and inconsistencies.
Apply quality control procedures to ensure data accuracy and integrity.
Review project documents such as protocols, CRFs, and Data Management Plans.
Assist in the development and review of Data Management and Quality Management Plans.
Assist in database design and annotation of CRFs.
Develop and test data validation checks and special listings.
Collaborate with the Lead Data Manager or Lead Data Reviewer to meet project milestones.
Ensure compliance with client and internal quality standards.
Support and respond to internal and client audits.
Mentor and train project staff on data management processes.
Perform other duties as assigned.

Qualifications (Minimum Required):

Bachelor's degree in life sciences, health sciences, information technology, or a related field (or equivalent experience).

Experience (Minimum Required):

4 to 6 years of Clinical Data Management experience.
Knowledge of clinical trial processes, DM, clinical operations, and biometrics.
Strong time management skills with the ability to meet project deadlines.
Ability to work collaboratively in a team environment.
Strong organizational, communication, and interpersonal skills.
Knowledge of medical terminology and a scientific background are preferred.

Preferred Qualifications Include:

Thorough knowledge of Fortrea's structure and Standard Operating Procedures (SOPs).
Two or more years of experience with Electronic Data Capture.

Physical Demands/Work Environment:

Office and/or home-based work environment.

Equal Opportunity Employer:

Fortrea is committed to diversity and inclusion in the workforce. The company does not tolerate discrimination or harassment and makes employment decisions based on business needs and individual qualifications. Fortrea encourages all qualified individuals to apply.

For more information, visit www.fortrea.com.

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