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 escal 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 tostudy 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 General 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 acceptancetesting (UAT).- Review, approve, and appropriately escal 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 needsand 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; elevate 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 assignedQualifications (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) andPost-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 skillsPreferred 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.Learn more about our EEO & Accommodations request here.#J-18808-Ljbffr

📌 Manager, Centralized Monitoring (Buenos Aires)
🏢 Fortrea
📍 Buenos Aires