Manager, Centralized Monitoring

Job Overview:

• Reviews trip reports proactively identifies risks and communicate any trends outstanding issues safety concerns to the study team.
• Responsible for the execution of key Central monitoring activities (Site region & study level review as applicable) and collaborates with the study team to execute Central Monitoring activities and comply with client expectations and notify any changes/risk and escalate as appropriate.
• Critical role in ensuring full implementation of the risk plan and recommending appropriate changes to ongoing monitoring.
• Provides people leadership for a team of 8-20 encompassing performance management coaching resource planning and hiring and continuous process improvement to ensure high-quality delivery.

Summary of Responsibilities:

• Review monitoring trip reports to ensure quality compliance and implementation of best practices; collaborate with project teams to revise project plans as needed.
• Proactively identify risks trends protocol deviations safety concerns and outstanding issues from trip reports; communicate findings to study teams and ensure issues are tracked through resolution.
• Act as a liaison between CRAs CTLs and Project Managers to support timely issue escalation and resolution.
• Train and mentor CRAs IHCRAs and new CMLs on trip report writing monitoring activities ICHGCP SOPs and local work instructions.
• Develop and maintain trip report templates and guidelines.
• Perform document review activities including eTMF reconciliation protocol deviation review and trending issue management and study analytics.
• Serve as the primary point of contact for communication with Global CTLs and Project Managers.
• Act as study lead for centralized monitoring and oversee site regional and studylevel central monitoring activities across multiple studies.
• Provide oversight and support to central monitoring teams to ensure accurate tracking analysis and reporting of study risks and monitoring status.
• Support development of detailed study risk assessments including risk factor definitions trigger thresholds SDV strategies mitigation plans and contributions to the Risk Assessment and Categorization Tool (RACT).
• Manage a portfolio of studies for assigned customers and act as a key customer point of contact.
• Oversee tracking interpretation and application of data to proactively manage risk and recommend changes to monitoring strategies and intervention levels.
• Support development of Critical Data and Critical Process Definitions.

• Contribute to study specific XRR dashboard development including design and refinement of dashboards and visualizations aligned with study data sources (e.g. EDC CTMS).

• Draft maintain and update Central Monitoring Plans Configuration Plans and related controlled documents in alignment with evolving risk profiles standard risk libraries and study changes.
• Configure central monitoring tools studyspecific risk factors trigger thresholds and parameters; perform user acceptance testing (UAT).
• Review approve and appropriately escalate changes to monitoring levels in compliance with applicable plans and sponsor requirements.
• Plan lead conduct and follow up on central monitoring activities; perform ongoing dashboard and analytics reviews and provide datadriven recommendations.
• Coach and mentor internal and external project teams to enhance centralized and riskbased monitoring capability.
• Support PMO activities including preparation of the Risk Management Register Study Risk Impact Reports and site risk weighting.
• Contribute to central monitoring proposal development bid defence materials costing reviews and sponsor presentations.
• Oversee Project Quality and Risk Reports to ensure compliance and client satisfaction.
• Provide technical leadership to study teams to ensure effective implementation of monitoring processes tools and riskbased approaches.
• Contribute to SOP development process mapping and continuous improvement initiatives using LEAN and Six Sigma methodologies.
• Identify evaluate and propose process system and tool improvements with appropriate justification.
• Manage assigned projects under the direction of a Project Manager or Director and ensure timely and effective communication with clinical operations teams.
• Ensure all monitoring activities comply with Fortrea SOPs ICHGCP and regulatory requirements.
• Follow established issue escalation and corrective action processes and proactively identify opportunities for improvement.
• Complete required training within defined timelines and support development and maintenance of training materials.
• Promote effective crossfunctional collaboration among internal and external stakeholders.

• Provide direct people management for assigned staff (820 direct reports) including supervision performance management (PMD IDPs goals) coaching and resolution of performance issues.
• Measure and monitor performance indicators; identify training needs and support training and development efforts.
• Provide GCP and quality oversight by ensuring required training is completed understood and implemented; identify and resolve GCP/quality issues through appropriate corrective actions.
• Hold staff accountable for quality compliance with Fortrea and client SOPs and adherence to deliverable timelines; support onboarding and rolespecific training (e.g. GCP quality).
• Ensure site monitoring activities comply with Fortrea SOPs ICHGCP and applicable work instructions; support inspection readiness and regulatory authority inspections.
• Communicate workload status for metric reporting; review billable hours utilization and productivity against budgets; escalate outliers and support mitigation.
• Support resource planning recruitment (screening/interviewing) expense management and financial authority per approval matrix.
• Promote standardized processes and tools; participate in process improvement initiatives (e.g. Six Sigma/LEAN) to enhance efficiency and productivity.
• Perform other duties as assigned

Qualifications (Minimum Required):

• University/College Degree (Life Science preferred) or certification in an allied health profession from an appropriate accredited institution (Eg: Nursing Certification Medical or Laboratory Technology) and

Post-graduation in Life sciences or any other applicable qualification and experience is recommended.

• Language: Speaking/Writing/Reading: English and Fluent in local language.
• Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.

Experience (Minimum Required):

• Years of experience in the job discipline: 2 years (Inclusive of Trip report review and/or Centralized monitoring/Risk based monitoring experience.
• Years of experience in other profession roles: 10-12 years of Clinical research experience.
• Working knowledge of ICH GCP including internal regulatory requirements for the conduct of clinical development programs.
• Advanced computer skills (Eg: MS Office Suite: Word Excel Powerpoint)
• Other required work-related experiences:

• Demonstrated ability to plan prioritize organize and communicate effectively.
• Demonstrated detail focused analytical and problem-solving skills
• Strong interpersonal skills with ability to influence lead and work well with others.
• Ability to be part of process improvement initiatives.
• Demonstrated project and risk management skills

Preferred Qualifications Include:

• Knowledge of Fortrea and the overall structure of the organization.
• Knowledge of Fortrea standard operating procedures.

Physical Demands / Work Environment:

Office/Home-Based:

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.
• Occasional crouching stooping with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying or moving of objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

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