Medical Data Reviewer

IQVIA; Bengaluru; On-site; INR 700,000 - 900,000; Full time

Job summary

IQVIA in Bengaluru seeks a Clinical Data Reviewer to assess structured clinical patient data for plausibility, completeness, and readiness for the next review step. You will verify data against protocol requirements and identify data gaps needing clarification from sites.

You will review dosing records, adverse events, concomitant medications, laboratory results, and patient history to ensure accuracy and proper data flow. Collaboration with medical review staff is essential.

Qualifications

• BDS/MDS with 2 years of work experience.
• Understanding of clinical/medical data.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology.
• Excellent motivational, influencing and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• Strong customer focus skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Responsibilities

• Review structured clinical patient data for plausibility and completeness.
• Identify anomalies needing site clarification or investigation.
• Review investigation product dosing records for protocol adherence and potential misses.
• Review all reported Adverse Events and Concomitant Medications for completeness and compliance.
• Review inclusion and exclusion criteria to confirm eligibility.
• Ensure proper EOS information is documented for patient exit reasons.
• Review laboratory results for completeness and potential safety signals.
• Review patient medical history for completeness and impact on other data.
• Review Lines Listings for data accuracy across patients.
• Review status information and data flow reports and take appropriate actions.
• Serve as POC/Back-up POC.
• Interact with medical review staff to verify information and triage issues.
• Attend Kick-Off, weekly team, and client meetings as needed.

Skills

Clinical data understanding

Medical terminology

Pharmacology

Anatomy & Physiology

Coaching skills

Multitasking

Customer focus

Relationship building

Education

BDS or MDS

Job description

Job Overview

Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and to determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.

Essential Functions

• Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
• Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
• Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE
• Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
• Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial
• Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
• Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
• Review additional information, as necessary, to determine overall readiness of the patient information for next level review
• Review all supplied Line Listings to determine data accuracy across patients within a specified group of data points
• Review status information and data flow reports and take appropriate actions
• Serve as POC/ Back-up POC
• Interact with other Medical review staff to verify/clarify information and/or triage new data issues or prior identified action items
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.

Qualifications

• BDS/MDS with 2 years of work experience
• Understanding of clinical/medical data.
• Background in Medical Terminology, Pharmacology, Anatomy, and Physiology
• Excellent motivational, influencing and coaching skills
• Ability to work on multiple projects and manage competing priorities
• Strong customer focus skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.