RBQM Lead - Central Monitoring

Job Overview:

The Central Monitoring Manager has a critical role in ensuring full implementation of the risk plan and recommending appropriate changes to the ongoing monitoring. Collaborates within a matrix environment, communicates proactively internally and externally and across functions with key stake holders to ensure plans are proactively and effectively executed to meet client expectations. Expected to have a substantial working and industry knowledge of drug development and clinical trial execution. The role is responsible for the preparation and conduct of central monitoring (site, subject and study level review as applicable) activities on a series of sponsor projects or sponsor portfolio from proposal to study report. Conducts the central monitoring activities and recommends mitigations to project teams and oversees the findings at site, subject, and study level. Provides the necessary support to the study team.

Summary of Responsibilities:

• Performs the Central monitoring activities for multiple studies and ensures accurate tracking and status reporting of studies in their remit.
• Manage portfolio of studies for a customer and act as a customer point of contact.
• Collaborates in the development of Central Monitoring proposal text and review of costing, contributes to proposal strategy and development.
• Collaborates in the development of sponsor presentations/bid defense support.
• Oversees at a study/customer level the appropriate tracking, interpretation, and application of data to proactively manage risk.
• Ensures that tracking and status reporting are performed in a timely and accurate manner.
• Applies data to recommend any required changes.
• Leads, plans, prepares, conducts, and follows up the central monitoring (Site, subject and study level review as applicable) activities and supports less experienced team members.
• Supports PMO in preparation of initial Risk Management Register and may prepare, distribute, and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
• Ensures Critical Data and Process Definition are implemented in EDC design by Data Expert.
• Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels.
• Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
• Develop the Central Monitoring and other applicable plans and any subsequent changes.
• Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools.
• Performs ongoing dashboard reviews, prepares, and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution.
• Agrees potential changes to monitoring intervention level with project team in line with the applicable plans and escalates appropriately.
• Performs subject clinical reviews and take appropriate actions as applicable.
• Performs study analytics reviews as per the applicable plans and communicates the findings appropriately.
• Reviews and Approves changes to monitoring levels, ensuring compliance with applicable Plans and sponsor needs are met.
• Oversees Project Quality and Risk Reports to ensure client satisfaction and compliance.
• Coaches assigned project teams internally and externally to increase the central monitoring competence.
• Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
• Evaluates and collates process improvement suggestions and submits to leadership.
• Evaluates and submits ideas and justification for improved systems and tools to leadership.
• If acts as line manager, the following responsibilities apply:
• Line management responsibilities for the training, utilization, development, and performance of Central Monitoring and/or Medical Data Review Operations Staff.
• Assign and classify tasks to the employees.
• Supervise, mentor, and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of Competency standards.
• Looking after the workforce’s HR needs.
• Assist in recruitment of new staff.
• Budgeting and scheduling for work force required to perform tasks.
• Ensure the smooth functioning of department in the organization.
• Responsible for managing Performance review and issues of direct reports.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University / college degree or post-graduation from an appropriately accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Minimum of 7-9 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.

Preferred Qualifications Include:

• University / college degree or post-graduation in life science preferred.

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