ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Medical Data Reviewer (MDR), in close cooperation with the Medical Director (MD), sets up and coordinates the medical data review process, assists with medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the Biometrics team, most frequently but not limited to the Data Coordinator & Lead Data Manager and Clinical Data Scientist. Specifically, the MDR reviews medical data for consistency and medical plausibility and ensures that the data is comprehensive from a medical point of view across different studies and projects.
Primary Responsibilities:
• Prepares listings with medical data (vital signs, lab data, medical history, concomitant medication, etc.) for medical review for plausibility and consistency.
• Reviews and approves all test outputs of listings in collaboration with the MD and Biometrics team.
• Plans and coordinates together with MD the medical review cycles and runs standard/customized listings as needed according to timeline.
• Participates in or attends internal and client Kick-Off meetings, as needed.
• Supports business development activities by providing input into feasibility activities related to medical data review
• Independently drafts the Medical Data Review Plan (MDRP) according to ICON standards, contract and client expectations (AWARD report / Proposal)
• Independently coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF) and CRF Completion Guidelines (CGS).
• Raises and closes queries with minimal or w/o support of the Medical Director (MD).
• Conducts medical review of the data as per MDRP on incremental listings and subject profiles in close collaboration with MD, using pre-established criteria to assure that the data is medically plausible and to clarify inconstancies and missing Adverse Events (AE).
• Reviews data for protocol deviations.
• Coaches and mentors other medical team members, as needed.
Requirements:
• Registered Nurse or equivalent Health Care Professional or BSc in Biology and Scientific background
• Read, write and speak fluent English
• 3 years of relevant experience in clinical research
• Frequent use and general knowledge of industry practices, techniques, and standards.
• Solves a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors.
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 through the form below.
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