- Collaborates in the development of Central Monitoring proposal text and review of costing, contributes to proposal strategy and development when Central Medical Review is included
- Support Sponsor presentations / bid defenses.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Applies data to recommend any patient safety concerns
- Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
- Contributes to the Risk Assessment and Categorization Tool for topics related to medical review and considers risks when planning Xcellerate® Medical Review configuration
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation
- Supports the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
- Drafts and finalizes the Central Medical Review Configuration Plan. Maintains this Plan throughout the study including re-versioning as required.
- Drafts Central Monitoring /Central Medical Review Plans in collaboration with the Central Monitoring Manager (if applicable) and Project Physician and updates these on an ongoing basis including the refinement of visualizations and any change in data
- Manages configuration of Xcellerate® Medical Review (XMR) tool, programming of study specific visualizations included in XMR and performs user acceptance testing of the tool
- Performs ongoing Central Medical Review, discusses findings with Project Physician (internal and/or client) and ensures that identified issues are followed to resolution, and where required, that a report is written.
- May 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.
- Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
- Collaborates with other Central Monitoring activities to ensure consistency and effectiveness.
- Evaluates and collates process improvement suggestions and submits to leadership.
- Evaluates and submits ideas and justification for improved systems and tools to leadership.
- Provide training on the project and process to new team members.
- Mentoring of new team members.
- Line management of Medical Reviewers, if assigned
- Support department leadership with work assignments and coordination of work
- Develop client specific processes if needed
- Any other duties assigned by supervisor.
- If acts as line manager, the following responsibilities apply.
- Assign and classify tasks to the First Line managerial staffs or employees
- Supervise, Mentor and evaluate performance of staff to ensure career development, interpersonal skills and achievement of Competency standards.
- Looking after the work force’s HR needs
- In Collaboration with first line level manager, assist in recruitment of new staff to MDR/CM.
- Budgeting and scheduling for work force required to perform tasks
- Ensure the smooth functioning of Central Monitoring department in the organization
- Responsible for managing Performance review and issues of direct reports.
Medical doctors with 3-10 years of experience in medical practice/equivalent clinical research roles or Para professionals and Life science graduates with 2-14 years of clinical research/equivalent experience, e.g. clinical monitoring, data management, Medical Data review, informatics etc.
- Medical Doctors, Allied medical degrees, Post-graduation in Life sciences or any other applicable qualifications
- Willingness to work in shift based environment (either 2:30 PM to 11:30 PM / 5:30 AM to 2:30 PM)
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