Medical Data Review Physician
ICON plc
About the Role
The Medical Data Review Physician is a medically qualified professional who coordinates and conducts medical data review activities across assigned clinical projects, reviews medical coding, and ensures data is consistent, medically plausible, and comprehensive.
Key Responsibilities
- Performing medical data review in assigned clinical trials in alignment with project plans, protocol requirements, scope of work, and applicable Standard Operating Procedures (SOPs).
- Providing medical leadership for planning, set up, and management of medical data review activities within assigned projects.
- Responsible for medical data review deliverables with oversight and guidance from Medical Director (MD).
- Conducts medical data review as per MRP to verify medical plausibility, consistency, accuracy, identify missing or unclear information, and potential protocol deviations using medical judgment.
- Applies medical knowledge and critical thinking to perform holistic participant-level and project-level medical data reviews, along with aggregate review of data to identify trends, medical inconsistencies, and emerging risks.
- Oversees and manages medical queries through resolution in collaboration with the MD, client, and cross-functional teams.
- Provides medical review of coded terms for consistency, plausibility, and completeness.
- Prepares regular medical data review reports for approval by MD.
- Participates in internal and client meetings, as appropriate, to discuss data review status, timelines, and issue resolution.
- Oversees financial aspects of medical data review activities, with input from the MD and MDR Clinician.
- Supports documentation management activities, including accuracy checks, tracking, filing, audit preparation and participation, and provides responses to audit findings.
- Collaborates cross-functionally with Project Management and other stakeholders to ensure high-quality medical data review outcomes.
Requirements & Tech Stack
- Medically qualified professional.
- Experience in coordinating and conducting medical data review activities.
- Experience in reviewing medical coding.
- Experience in providing guidance for setting up medical data review, including review of eCRF forms, edit checks, and CRF guidelines.
- Experience in using medical judgment.
- Experience in applying medical knowledge and critical thinking.
- Experience in preparing medical data review reports.
- Experience in participating in internal and client meetings.
- Experience in managing medical queries.
- Experience in supporting documentation management activities.
Qualifications
This section was not explicitly defined in the raw text, but implied through responsibilities and requirements.