Medical Data Reviewer (R1097495) in Bangalore, India at IQVIA™

Date Posted: 11/6/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    11/6/2019
  • Job ID:
    R1097495

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE
Review structured clinical patient data output without direct access to medical charts to ensure medical plausibility and determine adherence to protocol and overall completeness and readiness of the supplied patient information for next level of review.
RESPONSIBILITIES
 Serve as a Subject level Data reviewer (SLDR) and identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy
 Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
 Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
 Review all reported Adverse Events (AEs) , Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
 Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial
 Review all laboratory results to ensure completeness of information and 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 any other information as necessary to determine overall readiness of the patient information for next level review
 Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items
 Serve as POC/ Back-up POC
 Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
 May act as a Clinical Data Scientist for performing data analytics by reviewing the visualizations and identify potential issues of concern
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 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
 Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree or educational equivalence; or High School diploma or educational equivalence and 5 years’ related work experience in Clinical practice or clinical research related field, or equivalent combination of education, training and experience
JOB DESCRIPTION

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Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1097495