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Medical Data Reviewer

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

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.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 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 Serve as POC/ Back-up POC 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 concernAll 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 Ability to establish and maintain effective working relationships with coworkers, managers and clientsQualifications JOB DESCRIPTIONMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor s degree or educational equivalence; or High School diploma or educational equivalence and 5 years related work experience in Clinical practice or clinical research related field, or equivalent combination of education, training and experience Page 2PHYSICAL 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
Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 5-10


Chemist | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
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