Central Monitoring Associate Manager

Job description

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. Summary of Responsibilities: • Review monitoring trip reports to ensure quality, compliance, and implementation of best practices; collaborate with project teams to revise applicable project plans as required. • 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 protocol deviation review and trending analysis, issue management, and other assigned CTL activities. • 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 delivery, tracking, and status reporting. • Support development of detailed study risk assessments, including prescriptive mitigation strategies, SDV strategies, study‑specific risk factor definitions, and variable trigger thresholds. • Contribute to the Risk Assessment and Categorization Tool (RACT) for central monitoring topics. • 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 documents in line with emerging risk profiles, standard risk libraries, and study changes. • Execute central monitoring reviews (site, regional, and study level) and perform study analytics reviews per applicable plans, job aids, and guidelines. • Perform ongoing reviews of XRR dashboards and analytics; recommend mitigation actions and propose changes to monitoring intervention levels as appropriate. • Configure central monitoring tools, including population and testing of study‑specific risk factors, adjustment of trigger levels, and central monitoring parameters. • Prepare, distribute, and file project quality, study, and risk reports in accordance with defined timelines. • Mentor and train new or junior CMLs on central monitoring responsibilities/activities. • Present XRR demonstrations to internal and external stakeholders, as required. • Manage assigned projects under the direction of a Project Manager or Director and ensure timely and effective communication with clinical operations teams. • Ensure site monitoring activities are conducted in compliance with Fortrea SOPs, ICH‑GCP, and applicable work instructions. • Follow established issue escalation and corrective action processes; proactively identify and support process improvement opportunities. • Complete required training within defined timelines and ensure training materials remain current. • Provide technical leadership to study teams to support effective implementation of monitoring processes, tools, and risk‑based approaches, including identification of study scope or risk profile changes. • Support inspection readiness activities and regulatory authority inspections. • Promote effective cross‑functional collaboration among internal and external stakeholders. • Evaluate and submit recommendations for process, system, and tool improvements with appropriate justification. • Review and support development of departmental training materials, SOPs, and work instructions aligned with process or tool updates. • 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) 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: 8-10 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: