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.
Learn more about our EEO & Accommodations request here.