.ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center 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.We have an exciting opportunity for a** Medical Data Reviewer** to join ICON Biotech's Medical Affairs team.**LOCATION**: Mexico (home-based)**OVERVIEW OF THE ROLE**:The Medical Data Reviewer (MDR), in close cooperation with the Medical Director (MD), sets up and coordinates the medical data review process, conducts medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the Clinical Data Science, Project Management, and Clinical Delivery teams. 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.- Prepares listings with medical data for medical review for plausibility and consistency- Drafts the Medical Data Review Plan (MDRP) and medical line items of the Integrated Data Review Plan (IDRP)- Assures MDRP consistency with other project plans (i.E. DMP), contracted scope of work, and ICON SOPs and procedures- Together with the ICON MD, reviews the electronic Case Report Form (eCRF), and CRF Completion Guidelines (CCG)- Manages CRF queries in cooperation with ICON MD, Sponsor and other departments- Participates in or attends internal and client Kick-Off meetings- Reviews the protocol together with the ICON MD to determine which standard outputs will be appropriate for medical review and decides whether any customized outputs are needed per study specific requirements- Reviews and approves all test outputs for medical data review in collaboration with the ICON MD and Clinical Data Science team- Plans and coordinates the medical review cycles and runs standard/customized outputs as needed according to timeline- Conducts medical review of the data as per MDRP and IDRP in close collaboration with ICON MD, using pre-established criteria to assure that the data is medically plausible and to clarify inconstancies and missing Adverse Events (AE)- Ensures a structured medical query management- Raises and responds to medical queries, following through until query resolution
