Med Data Review Assoc Mgr

About the Role

The Associate Medical Data Review Manager is an integral part of the Global Medical Review Team, focused on executing key Central Medical Review activities within the Central Monitoring strategy. This role involves collaboration in a matrix environment, proactive communication with internal and external stakeholders, and ensuring the effective execution of Central Monitoring/Central Medical Review Plans to meet client expectations. The role encompasses the preparation and conduct of Central Medical Review tasks from the launch of the Xcellerate® Medical Review tool through to study report finalization. Reviews are performed under the guidance of a Central Medical Review Plan, with findings communicated at the site and patient level, and oversight provided by the Project Physician.

Key Responsibilities

• Collaborate in the development of Central Monitoring proposal text and review of costing.
• Support proposal strategy and development when Central Medical Review is included.
• Support Sponsor presentations/bid defenses.
• Ensure timely and accurate tracking and status reporting.
• Apply data to recommend patient safety concerns.
• Identify and evaluate safety signals using individual cases, cumulative data assessment, and other signal detection systems.
• Contribute to the Risk Assessment and Categorization Tool for medical review topics and consider risks when planning Xcellerate® Medical Review configuration.
• Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
• Support the development of medical review requirements, including visualization design, considering study data feeds (EDC, laboratory, etc.).
• Draft and finalize the Central Medical Review Configuration Plan and maintain it throughout the study, including re-versioning.
• Draft Central Monitoring/Central Medical Review Plans in collaboration with the Central Monitoring Manager (if applicable) and Project Physician, and update them ongoingly.
• Manage configuration of the Xcellerate® Medical Review (XMR) tool, program study-specific visualizations within XMR, and perform user acceptance testing.
• Perform ongoing Central Medical Review, discuss findings with the Project Physician (internal and/or client), and ensure identified issues are resolved.
• Act as a subject matter expert based on education, qualification, or experience.
• Provide data-driven decisions and communicate findings proactively and effectively to key stakeholders.
• Ensure inspection readiness for medical assessment activities and support regulatory authority inspections.
• Collaborate with other Central Monitoring activities for consistency and effectiveness.
• Evaluate and collate process improvement suggestions and submit them to leadership.
• Evaluate and submit ideas and justification for improved systems and tools to leadership.
• Provide training on projects and processes to new team members.
• Mentor new team members.
• Perform other duties as needed or assigned.

Responsibilities if acting as line manager:

• Manage direct reports regarding staff training records, utilization targets, and exceeding targets per job grade.
• Cascade relevant information from internal and external meetings to direct reports and appropriate colleagues.
• Assist with recruitment of new staff.
• Ensure proper functioning and maintenance of tools and machinery.
• Convey organizational problems to senior managers.
• Manage performance reviews and issues of direct reports.
• Ensure the smooth functioning of the Central Monitoring department.

Requirements & Tech Stack

• Xcellerate® Medical Review (XMR) tool
• EDC (Electronic Data Capture)
• Laboratory data feeds
• Risk Assessment and Categorization Tool
• Central Monitoring/Central Medical Review Plans
• Central Medical Review Configuration Plan

Qualifications

• 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.

Work Environment

• Standard office or home working equipment required.
• Minimal travel required.