Manager, Centralized Monitoring

Fortrea; Buenos Aires; Hybride; ARS 136 310 000 - 212 038 000; Plein temps

Résumé du poste

Fortrea is seeking a Senior Central Monitoring professional to lead centralized monitoring across multiple studies and ensure quality and compliance. You will coach CRAs, IHCRAs, and CMLs, oversee risk-based monitoring, and drive process improvements using LEAN and Six Sigma methodologies.

You will collaborate with Global CTLs and Project Managers, manage study risk assessments, dashboards, and KPI reporting, and ensure adherence to ICH‑GCP and Fortrea SOPs, while supporting resource planning

Qualifications

• University/College Degree (Life Science preferred) or allied health certification.
• Post-graduation in Life sciences or related qualification recommended.
• English language skills and fluency in local language required.

Responsabilités

• Review monitoring trip reports for quality, compliance and best practices.
• Identify risks, trends, protocol deviations from trip reports and track until resolution.
• Act as liaison between CRAs, CTLs, and Project Managers for escalation.
• Train and mentor CRAs, IHCRAs, and new CMLs on SOPs and ICH‑GCP.
• Develop and maintain trip report templates and guidelines.
• Review eTMF reconciliation, protocol deviation review and study analytics.

Connaissances

People leadership

Mentoring

Communication

Risk management

Project management

Formation

Life science degree

Post-graduate qualification

Outils

MS Office

EDC/CTMS

Description du poste

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 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 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 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; 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 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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