[Hiring] Medical Data Reviewer @ICON plc

Role Description

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.

• 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 inconsistencies and missing Adverse Events (AE).
• Reviews data for protocol deviations.
• Coaches and mentors other medical team members, as needed.

Qualifications

• 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

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.