Clinical Data Specialist

3-5 years

Not Disclosed

Bangalore

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

📌 Clinical Data Specialist | Fortrea – Bangalore

💼 Company: Fortrea
📍 Location: Bangalore, India
🕒 Job Type: Full-Time
📑 Category: Data Management & Data Science
🆔 Job ID: 2447267

About Fortrea

Fortrea is a global contract research organization (CRO) that offers clinical development, patient access, and technology solutions across 20+ therapeutic areas. With operations in ~100 countries, Fortrea is committed to transforming drug and device development to benefit patients globally.

Position Overview

As a Clinical Data Specialist at Fortrea, you will be responsible for conducting clinical data review, generating and resolving queries, and assisting with the development and management of clinical data in accordance with client specifications. You will work closely with the Data Management team to ensure clinical data is delivered with quality and integrity, meeting project timelines and goals.

Key Responsibilities

📝 Clinical Data Review & Query Management:

Perform clinical data review in line with Data Management Plans and Data Review Guidelines.
Generate, resolve, and track queries related to erroneous or incomplete data.

⚙️ Support Data Management Systems:

Assist with the setup and maintenance of data management systems as per project requirements.
Contribute to the development of edit checks and eCRF specifications.

📊 Data Listings & Reports:

Run and execute special listings and reconciliation discrepancy listings for data review.
Generate status reports and database lock/unlock activities.

👥 Team Collaboration:

Work with project teams to support the setup, maintenance, and closure of Data Management activities.
Provide training to new staff on project-specific processes.

📚 Documentation & Administration:

Maintain eTMF and other project-related documentation.
Post data management documentation and perform administrative tasks as needed.

Qualifications

🎓 Education:

University/College degree in life sciences, health sciences, information technology, or related fields.

💼 Experience:

3-5 years of relevant experience in data management, with expertise in one or more therapeutic areas.
Experience in clinical trial data review and a solid understanding of data management practices.

📝 Skills:

Time management and ability to adhere to project timelines.
Good oral and written communication skills.
Collaborative mindset and ability to work within a team environment.

Preferred Qualifications

Knowledge of Fortrea and the organization’s structure.
Familiarity with Fortrea standard operating procedures (SOPs).

Why Join Fortrea?

Fortrea offers an opportunity to be part of an innovative CRO focused on improving clinical trials and advancing life-changing therapies. The company promotes a collaborative workspace that nurtures personal growth and offers global impact in drug and device development.

How to Apply

Interested candidates can apply online for this role.

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Clinical Data Specialist

Job Description

About Fortrea

Position Overview

Key Responsibilities

Qualifications

Preferred Qualifications

Why Join Fortrea?

How to Apply

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