Medical Data Review Specialist Ii

3-7 years

Not Disclosed

Bangalore

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Medical Data Review Specialist II
Company: Fortrea, a Global Contract Research Organization (CRO)
Location: [Insert Location]

Job Overview:

Fortrea is a leading global contract research organization (CRO) providing pharmaceutical, biotechnology, and medical device customers with comprehensive clinical development, patient access, and technology solutions. We are seeking a Medical Data Review Specialist II to join our Global Medical Data Review Team. This senior role will be responsible for executing Central Medical Review activities, assisting senior staff and Medical Monitors, and ensuring compliance with central monitoring plans. The specialist will conduct medical reviews, track safety signals, and collaborate with the study team to ensure patient safety during clinical trials.

Key Responsibilities:

Medical Review & Data Analysis:
- Perform ongoing Central Medical Reviews for multiple studies under the guidance of a Medical Review Plan.
- Communicate findings at the patient level with the study team.
- Identify and evaluate safety signals based on individual case and cumulative data assessment.
- Apply data to recommend patient safety concerns and escalate issues as needed.
- Draft and maintain Central Medical Review Configuration Plans, ensuring accurate and updated documentation throughout the study.
Collaboration & Reporting:
- Work with the study team to execute the central monitoring aspects of clinical trials.
- Draft and update the Central Monitoring and Medical Review Plans.
- Prepare and distribute quality reports during the study and at study close-out.
- Ensure study documents are filed properly and are inspection-ready.
Process Improvement & Training:
- Identify and propose process improvements for current issues in medical review activities.
- Support the implementation of systems and tool improvements for medical review.
- Mentor and train new team members, ensuring their smooth integration into the project and processes.
Stakeholder Communication & Compliance:
- Provide data-driven decisions and communicate findings to key stakeholders.
- Support regulatory authority inspections when needed and ensure compliance with inspection readiness.
- Track Request for Proposal (RFP) opportunities and project/study status accurately.

Qualifications (Minimum Required):

Education:
- Medical degree (MD), Allied medical degrees, or Post-graduation in Life Sciences. Fortrea may consider relevant equivalent experience in lieu of formal educational requirements.
Experience:
- 3-5 years of experience in medical practice or clinical research roles (for Medical Doctors).
- 5-7 years of experience in clinical research (for paraprofessionals or Life Sciences graduates), including clinical monitoring, data management, or medical data review.
Language Skills:
- Proficient in English (both spoken and written).

Physical Demands/Work Environment:

Standard office or home working equipment required.
Minimal travel required.

Fortrea is an Equal Opportunity Employer:

Fortrea is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We encourage all individuals to apply, regardless of race, religion, color, national origin, gender, family or parental status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic.

For more information about how we collect and store personal data, please refer to our Privacy Statement.

If you require reasonable accommodation due to a disability to complete your job application, pre-employment testing, or interview process, please contact: taaccommodationsrequest@fortrea.com. This email is only for job seekers requesting accommodations.

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Medical Data Review Specialist Ii

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