Job Description:
Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy and medical consistency
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, patient profiles 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.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Quintiles
0 – 3 yrs Bengaluru/Bangalore
Keyskills:
medical reviewer M.B.B.S clinical research clinical trial clinical data medical documentation medical data
Desired Candidate Profile:
Education-
UG: MBBS – Medicine
PG:Post Graduation Not Required
Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required
Company Profile:
Quintiles
Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. With a network of more than 30,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.
Email Address:Sukhad.pandey@quintiles.com