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Senior Medical Data Reviewer - (1722618) in Bangalore, IN at IQVIA™

Date Posted: 2/15/2018

Job Snapshot

Job Description

IMS Health and Quintiles have come together to be IQVIA. We have created a new way to harness advances in technology, analytics and human ingenuity called Human Data Science, to deliver solutions that help our customers drive healthcare forward and help patients around the globe. Inspired by the industry we help, our employees are committed to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.

PURPOSE

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.

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 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

 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



Job Requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Medic with 5 year college degree or MBBS; or Bachelor’s degree in clinical, biological, mathematical sciences, or related field, or nursing qualification, with 1 year of relevant work experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

 Extensive use of telephone and face-to-face communication requiring accurate perception of speech

 Extensive use of keyboard requiring repetitive motion of fingers

 Regular sitting for extended periods of time.

Meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimage healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and help patients around the globe. Whatever your career goals, we're here to confidently get you there!



Job ID: 1722618