Medical Data Review Specialist Ii

5-7 years

Not Disclosed

Bangalore

10 March 3, 2025

Job Description

Job Type: Full Time Education: MD/MBBS/DO 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

Medical Data Review Specialist II

Location: Bangalore
Category: Clinical
Job ID: 25817

Job Overview:
The Medical Data Review Specialist II is a senior member of the Global Medical Data Review Team, responsible for executing key Central Medical Review activities. This role involves supporting senior staff and Medical Monitors, collaborating with study teams to ensure compliance with central monitoring plans, and reviewing clinical trial data for accuracy and patient safety.

Key Responsibilities:

Perform ongoing Central Medical Review for multiple studies per the Medical Review Plan.
Support the completion of Critical Data and Process Definition with Data Management input.
Identify and evaluate safety signals using individual cases, cumulative data assessments, and signal detection systems.
Ensure accurate tracking and timely reporting of study data.
Recommend patient safety concerns based on data review.
Contribute to risk assessment tools related to medical review and monitoring.
Support medical review requirements, including visualization design for data feeds (EDC, laboratory, etc.).
Draft and maintain the Central Medical Review Configuration Plan.
Collaborate with study teams to refine Central Monitoring and Medical Review Plans.
Discuss Central Medical Review findings with study teams and other stakeholders.
Act as a subject matter expert based on education and experience.
Provide data-driven insights and communicate findings effectively.
Prepare and distribute quality reports during and after study completion.
Maintain proper filing of study documents for inspection readiness.
Assist in regulatory inspections when required.
Track study progress and propose process improvements.
Mentor new team members and provide training on projects and processes.

Qualifications:

Minimum Requirements:

Medical Doctor (MD), Allied Medical Degree, Post-graduation in Life Sciences, or equivalent qualifications.
Relevant and equivalent experience may be considered in lieu of formal education.

Experience:

For Medical Doctors: 3-5 years in medical practice or clinical research.
For Paraprofessionals & Life Science Graduates: 5-7 years in clinical research, clinical monitoring, data management, medical data review, or informatics.

Language Skills:

Speaking: English required.
Writing/Reading: English required.

Work Environment & Travel:

Standard office or home-based work setup.
Minimal regional travel required.

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Medical Data Review Specialist Ii

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