Job Overview:
The Associate Medical Data Review Manager is an important member of the Global Medical Review Team with responsibility for execution of key Central Medical Review activities within the Central Monitoring strategy, such as: Collaborate within a matrix environment, communicate proactively internally and externally and across functions with key stakeholders to ensure Central Monitoring/Central Medical Review Plans is proactively and effectively executed to meet client expectations. Responsible for the preparation and conduct of Central Medical Review tasks across a series of sponsor projects commencing with Xcellerate® Medical Review tool launch up to and including the study report. Conduct reviews of Central Medical Review under guidance of a Central Medical Review Plan and communicates findings at the site, patient level. This review is performed with oversight by the Project Physician who also acts as an escalation point for the Medical Reviewer-Central Monitoring. Provide Central Medical Review support to the study team and to the client.
Summary of Responsibilities:
- 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 and 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[1]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.
- All other duties as needed or assigned.
- If acts as line manager, the following responsibilities apply:
- Manage direct reports to ensure staff training records are up to date, ensure utilization targets are met to exceed target, per job grade.
- Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
- Assist with recruitment of new staff.
- Ensure the proper functioning of the tools and machinery, and their maintenance.
- Convey the problems faced by the organization to senior managers, etc., thus creating the base for the top management to work upon.
- Responsible for managing Performance review and issues of direct reports.
- Ensure the smooth functioning of the Central Monitoring department in the organization.
Qualifications (Minimum Required):
- Medical Doctors, Allied medical degrees, Post-graduation in Life sciences or any other applicable qualifications.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Demands/Work Environment:
- Standard office or home working equipment required.
- Minimal travel required.
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