Central Monitoring Associate Manager

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 ICHGCP 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 studylevel 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 studyspecific 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 studyspecific 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 ICHGCP 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 riskbased approaches including identification of study scope or risk profile changes.
• Support inspection readiness activities and regulatory authority inspections.
• Promote effective crossfunctional 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:

• 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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