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.
Post : Senior Central Monitor
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
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Qualifications
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.
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
Additional Information:
Qualification: Bachelor’s degree, MBBS
Location: Maharashtra-Thane
Industry Type: Pharma
End Date: 28th June, 2017
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