Role Description
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.
Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders, and providing guidance for setting up medical data review, including review of eCRF forms, edit checks, and CRF guidelines, in collaboration with the MD.
Key Responsibilities
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Performing medical data review in assigned clinical trials in alignment with project plans, protocol requirements, scope of work, and applicable Standard Operating Procedures (SOPs).
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Providing medical leadership for planning, set up, and management of medical data review activities within assigned projects.
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Responsible for medical data review deliverables with oversight and guidance from Medical Director (MD), as appropriate.
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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.
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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.
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Oversees and manages medical queries through resolution in collaboration with the MD, client, and crossβfunctional teams.
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Provides medical review of coded terms for consistency, plausibility, and completeness.
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Prepares regular medical data review reports for approval by MD.
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Participates in internal and client meetings, as appropriate, to discuss data review status, timelines, and issue resolution.
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Oversees financial aspects of medical data review activities, with input from the MD and MDR Clinician.
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Supports documentation management activities, including accuracy checks, tracking, filing, audit preparation and participation and provides responses to audit findings.
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Collaborates cross-functionally with Project Management and other stakeholders to ensure high-quality medical data review outcomes.
Qualifications
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Medically qualified professional.
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Experience in clinical research and medical data review.
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Strong medical knowledge and critical thinking skills.
Requirements
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Ability to work closely with teams and stakeholders.
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Experience with eCRF forms, edit checks, and CRF guidelines.
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Proven track record in managing medical data review activities.
Benefits
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Competitive base salary and performance-related incentives.
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
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Retirement and pension plans.
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Life assurance and disability coverage.
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Employee assistance programmes and wellbeing resources.
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Learning and development opportunities through structured training and career pathways.
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Benefits may vary depending on role and location.