As a Medical Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
o Reviewing patient medical data (both – ongoing per subject and cumulative medical data review) according to the Medical Review Plan (MRP) during the course of the study to indentify possible safety issues and to ensure the medical integrity of the data
o Medical queries: posting, tracking, etc.
o Reviewing Clinical Study Report (CSR) narratives
o Medical input to the Protocol, Protocol amendments and other Study documents, e.g. Patient information/informed consent from and Health authority, IRB/EC submission relevant documents
o electronic CaseReportForm development / perform UserAcceptanceTest
o Review of medical event lists and issue queries
o Preparation of the medical review summary reports according to therequirements specified in the MRP
o Reviewing code lists
o Validity review meetings and other study meetings
o Clinical study report development
o Review of statistical tables and listings
o Review of the medical sections of the clinical study report
o Medical trainings of internal or external study team members
- Required to have 4-5 years of experience working as a Medical Reviewer
- Cardiology experience needed
- Must have previous pharma / clinical trial experience
- The right candidate will have strong understanding of clinical trial regulations in the clinical research industry and regulatory institutions (ICH, FDA, EMA)
- Exposure to working in different therapeutic areas and diseases
- Should have exposure to protocol writing and evaluating
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Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
