- Performs ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan or any applicable documents and communicates findings at patient with Team.
- Support team to ensure Critical Data & Process Definition is completed with Data Management and input from project team and supports implementation of critical data focused EDC design.
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Applies data to recommend any patient safety concerns
- Contributes to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning tools configuration
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation
- Support the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Draft the Central Medical Review Configuration Plan. Maintains this Plan throughout the study including re-versioning as required.
- Draft Central Monitoring /Central Medical Review Plans in collaboration with the study team and updates these on an ongoing basis including the refinement of visualizations and any change in data.
- Performs ongoing Central Medical Review, discusses findings with the study team
- Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
- Act as subject matter expert based on education qualification/experience.
- Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
- Prepare and distribute the quality reports at intervals during study conduct and at study close out.
- Ensures filing of study documents in the central files in a central office or hub location
- Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
- Track Request for Proposal opportunities and Project/Studies and their status accurately
- Proposes process improvements and solutions to current process issues.
- May support the implementation of ideas into systems and tools improvements.
- Provide training on the project and process to new team members.
- Mentoring of new team members.
- Any other duties assigned by supervisor.
Medical Doctors, Allied medical degrees, Post-graduation in Life sciences or any other applicable qualifications
Medical doctors with 3-5 years of experience in medical practice/equivalent clinical research roles or Para professionals and Life science graduates with 5-7 years of clinical research/equivalent experience e.g. clinical monitoring, data management, Medical Data review, informatics etc.
Experience in medical data review preferred
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