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Medical Data Review Manager

5 years
Not Disclosed
10 Nov. 14, 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 Description – Medical Data Reviewer

Job Overview

The Medical Data Reviewer is responsible for reviewing structured clinical patient data outputs (without direct access to medical charts) to ensure medical plausibility, protocol adherence, and overall completeness of patient information before it moves to the next level of review.


Key Responsibilities / Essential Functions

1. Patient Data Review

  • Identify anomalies or inconsistencies in patient-reported data and request clarification from clinical sites.

  • Assess inclusion and exclusion criteria to confirm patient eligibility for the clinical trial.

  • Review investigational product dosing records to verify protocol adherence and detect missed or inaccurate dosages.

2. Safety & Medical Information Review

  • Assess all reported Adverse Events (AEs), Concomitant Medications, and Medical History for plausibility and protocol alignment.

  • Evaluate medical information to ensure completeness and check for inconsistencies with other reported data (e.g., AEs, lab results).

3. Study Milestones Verification

  • Verify documentation of End of Treatment (EOT) and End of Study (EOS) information, ensuring accuracy of the reason for discontinuation.

4. Laboratory Data Review

  • Review lab results for completeness, protocol compliance, and potential safety signals that may not be documented as AEs.

5. Data Readiness Assessment

  • Evaluate all available patient data to ensure readiness for next-level review.

  • Review additional clinical information as required.

6. Cross-functional Collaboration

  • Interact with Medical Review team members to validate information and resolve data issues.

  • Support triage of new or ongoing data discrepancies.

7. Meetings & Communication

  • Participate in Kick-Off Meetings, weekly team meetings, and client discussions as required.


Qualifications

Education

  • Bachelor’s Degree (Required)
    OR

  • High School Diploma (or equivalent) with 5 years of relevant experience in clinical practice or clinical research (Required)
    OR

  • Equivalent combination of education, training, and experience.

Knowledge & Skills

  • Strong understanding of clinical/medical data.

  • Background in:

    • Medical Terminology

    • Pharmacology

    • Anatomy & Physiology

  • Excellent motivational, influencing, and coaching abilities.

  • Strong organizational skills with the ability to manage multiple projects and competing priorities.

  • Strong customer focus and problem-solving mindset.

  • Ability to build and maintain effective working relationships with coworkers, managers, and clients.