Medical data review manager
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Job Location:
Monthly Salary:
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
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
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
