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Medical Data Review Manager

1-5 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Hybrid 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: Clinical Data Reviewer / Medical Data Reviewer

Job Overview

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


Key Responsibilities

1. Patient Data Review

  • Identify anomalies or inconsistencies in patient-reported data and follow up with clinical sites for clarification.

  • Review inclusion and exclusion criteria to confirm each patient’s eligibility for the clinical trial.

  • Verify investigational product dosing records to ensure protocol adherence and identify missed or inaccurate dosages.

2. Safety & Medical Information Review

  • Review Adverse Events (AEs), Concomitant Medications (CMs), and Medical History (MH) for accuracy, medical plausibility, and protocol adherence.

  • Ensure alignment between clinical findings (e.g., AEs, labs, medications) and protocol expectations.

3. Study Milestones Verification

  • Confirm correct documentation for End-of-Treatment (EOT) and End-of-Study (EOS) statuses and primary reasons for discontinuation.

4. Laboratory Data Review

  • Assess laboratory results for completeness and timing according to the protocol schedule.

  • Identify potential safety concerns indicated by lab values that may not be reflected in AE reporting.

5. Cross-functional Collaboration

  • Communicate with Medical Review staff to resolve data issues or verify patient-level information.

  • Support triage of new and ongoing data action items.

6. Meetings & Communication

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


Qualifications

Education

  • Bachelor’s Degree (preferred), OR

  • High School Diploma with 5 years of clinical practice or clinical research experience, OR

  • Equivalent combination of education, training, and relevant experience.

Knowledge & Skills

  • Strong understanding of clinical/medical data.

  • Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.

  • Ability to manage multiple projects and competing priorities.

  • Strong customer focus and teamwork orientation.

  • Excellent influencing, motivational, and coaching skills.

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