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:**