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.
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