Medical Data Reviewer

at  ICON

MEDICAL DATA REVIEWER

Location: Dublin/Ireland (Note: Hybrid Position: 2 days home, 3 days office)
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 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 Biometrics team, specifically, the MDR reviews medical data for medical plausibility and ensures that the data is comprehensive from a medical point of view across different studies and projects.

RESPONSIBILITIES:

• Prepares listings with medical data (vital signs, lab data, medical history, concomitant medication, etc.) for medical review for plausibility.
• Under close supervision, coordinates and drafts the Medical Data Review Plan (MDRP) according to ICON standards, contract and client expectations. Assures MDRP consistency with contracted scope of work, and ICON SOPs and procedures.
• Reviews the electronic Case Report Form (eCRF), and CRF Completion Guidelines (CCG).
• Manages queries in cooperation with ICON MD, Sponsor and other departments.
• Participates in or attends internal and client Kick-Off meetings, as needed.
• Reviews the protocol together with the PRA MD to determine which standard listings will be appropriate for medical review and decides whether any customized listings are needed per study specific requirements.
• 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.
• Ensures a structured medical query management
• Raises and responds to medical queries following through until query resolution.
• Reviews and responds to Quality Control (QC) findings, as needed
• Supports business development activities by providing input into feasibility activities related to medical data review