Medical data review manager

Job Overview

Review structured clinical patient data output without direct access tomedical 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.

Essential Functions

Identify any anomalies in patient reported data 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

Attend Kick-Off meetings weekly team meetings and client meetings as needed or requested.

Qualifications

Bachelors Degree Req Or

High School Diploma or equivalent with 5 years related work experience in Clinical practice or clinical research related field Req

Equivalent combination of education training and experience in lieu of degree Req

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

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

Required Experience :

Manager

Key Skills

SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1