18452-Medical Data Review Mgr

Job Overview

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.

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

• Bachelor's Degree
• High School Diploma or equivalent with 5 years’ related work experience in Clinical practice or clinical research related field
• Equivalent combination of education, training and experience  in lieu of degree
• 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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.