**Job Overview**:
**Summary of Responsibilities**:
- Performs the Central monitoring activities for multiple studies and ensures accurate tracking and status reporting of studies in their remit.
- Manage portfolio of studies for a customer and act as a customer point of contact.
- Collaborates in the development of Central Monitoring proposal text and review of costing, contributes to proposal strategy and development.
- Collaborates in the development of sponsor presentations/bid defense support.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Applies data to recommend any required changes.
- Supports PMO in preparation of initial Risk Management Register and may prepare, distribute, and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
- Ensures Critical Data and Process Definition are implemented in EDC design by Data Expert.
- Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels.
- Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
- Develop the Central Monitoring and other applicable plans and any subsequent changes.
- Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools.




- Performs ongoing dashboard reviews, prepares, and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution.
- Agrees potential changes to monitoring intervention level with project team in line with the applicable plans and escalates appropriately.
- Performs study analytics reviews as per the applicable plans and communicates the findings appropriately.
- Reviews and Approves changes to monitoring levels, ensuring compliance with applicable Plans and sponsor needs are met.
- Oversees Project Quality and Risk Reports to ensure client satisfaction and compliance.
- Coaches assigned project teams internally and externally to increase the central monitoring competence.
- Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
- Evaluates and collates process improvement suggestions and submits to leadership.
- Evaluates and submits ideas and justification for improved systems and tools to leadership.
- ** If acts as line manager, the following responsibilities apply**:
- Line management responsibilities for the training, utilization, development,



and performance of Central Monitoring and/or Medical Data Review Operations Staff.
- Assign and classify tasks to the employees.
- Supervise, mentor, and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of Competency standards.
- Looking after the workforce’s HR needs.
- Assist in recruitment of new staff.
- Budgeting and scheduling for work force required to perform tasks.
- Ensure the smooth functioning of department in the organization.
- Responsible for managing Performance review and issues of direct reports.
- All other duties as needed or assigned.
**Qualifications (Minimum Required)**:
- University / college degree or post-graduation from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
**Experience (Minimum Required)**:
- Minimum of 7-9 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.
**Preferred Qualifications Include**:
- University / college degree or post-graduation in life science preferred.
**Physical Demands/Work Environment**:
- Standard office or home working equipment required.
- ** Travel Requirements**:
- Local, Domestic, Integral.
- ** Identify the expected travel requirements of the position on an annual basis**:
- % of time:15%.
Learn more about our EEO & Accommodations request here.

📌 Central Monitoring Manager (Ciudad de México)
🏢 Fortrea
📍 Ciudad de México