Quintiles jobs "A"

Openings for Medical Data Reviewer@quintiles (2-5 Years Exp)-only MBBS

Quintiles

2 - 5 yrs

Thane

Job Description

Multiple Job Openings for Medical Data Reviewers having MBBS degree


PURPOSE
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 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
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelors 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

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


Job Location - Thane


POC - Goldy H Sachdev

Company Profile:

Quintiles

Quintiles
Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health . A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

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