Manager, Centralized Monitoring
# Manager, Centralized Monitoring **Fortrea** · São Paulo, SP · `On-site` 🕒 **Статус:** *Опубликовано: 3 дня назад* · *Источник: Indeed* --- ### About the Role 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, ICH‑GCP, 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 study‑level 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, study‑specific 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 data‑driven recommendations. - Coach and mentor internal and external project teams to enhance centralized and risk‑based 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 risk‑based 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, ICH‑GCP, 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 cross‑functional collaboration among internal and external stakeholders. - Provide direct people management for assigned staff (8–20 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 role‑specific training (e.g., GCP, quality). - Ensure site monitoring activities comply with Fortrea SOPs, ICH‑GCP, 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.
Наблюдалась 2026-10-15, впервые 2026-10-12, источник — Indeed.