Medical Data Reviewer
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.
• 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.
• Other Medic with 5 year college degree or MBBS Req Or
• Bachelor's Degree Clinical, biological, mathematical sciences, or related field, or nursing qualification, with 1 year of relevant work experience 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
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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