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Openings for Medical Data Reviewer

By: Pharma Jobs | Views: 643 | Date: 04-Jun-2016

Multiple Job Openings for Medical Data Reviewers having Life Science/ Pharma graduate/ post - graduate degrees

    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


    Contact Person - Goldy H Sachdev

    Contact: Goldy.Sachdev@Quintiles.com

    Job Location :


    12th Floor, G Corp Tech Park, 
    Next to Hypercity Mall, 
    Ghodbunder Rd, Thane, 
    Maharashtra 400601


Salary:Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Other

Role Category:Other

Role:Other

Keyskills

Clinical ResearchMedical officermedical data reviewerMDRPVClinical Data ManagementData ManagementClinicalCRACRClife sciencepharmanursingBiotechnology

Desired Candidate Profile

Education-

UG:B.Sc - Any Specialization, B.Pharma - Pharmacy

PG:Post Graduation Not Required, M.Sc - Any Specialization, M.Pharma - Pharmacy

Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

    Please refer to the Job description above
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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