Central Monitoring Operations Manager - FSP

• *Work Schedule**

Standard (Mon\-Fri)**Environmental Conditions**

Office**Job Description**

• *Summarized Purpose:**
• ----------------------

Acts as a Subject Matter Expert (SME) and interdepartmental and client liaison for data analytics activities.

• Focuses on developing tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks.
• Leads one or more projects, including setting up functional plans, monitoring tools, and data review cycles.
• Provides expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight.
• Ensures effective risk identification, trend analysis, and signal detection to support trial quality, patient safety, and data integrity.

• *Essential Functions and Other Job Information:**
• -------------------------------------------------

• Accountable for **site monitoring strategy and oversight**, including authoring risk assessments and monitoring plans.
• Ensure effective **sponsor oversight, trend analysis, and signal detection** to support trial quality and delivery.
• Provide **site monitoring expertise** to the trial team and lead the implementation of monitoring and oversight approaches.
• Oversee **planning, execution, and issue management** of site monitoring activities across all R/OPUs.
• Ensure compliance with **protocols, ICH\-GCP, regulatory requirements**, and maintain inspection readiness.
• Safeguard **patient safety, data integrity, and trial outcomes** through effective monitoring oversight.
• Lead centralized monitoring activities, including the development of study\-specific tools, monitoring plans, and data review processes.
• Perform complex data reviews, risk signal analysis, trend analysis, and root cause analysis to identify and mitigate potential risks.
• Monitor **Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Risk\-Based Quality Management (RBQM)** activities.
• Manage review timelines, analysis assignments, project deliverables, and support budget management.
• Coordinate with internal teams, sponsors, and cross\-functional stakeholders to ensure timely and high\-quality deliverables.
• Prepare and deliver centralized monitoring reports and lead monitoring review meetings.
• Participate in cross\-functional risk assessment meetings and contribute to overall risk planning and mitigation strategies.
• Develop and enhance monitoring tools, dashboards, and analytical processes to improve risk detection and operational efficiency.
• Provide training, mentoring, and guidance to junior team members.
• Act as a project lead, development specialist, or a combination of both, depending on project requirements.

• *Qualifications:**
• ------------------

### **Education and Experience:**

• **Bachelor's degree in Life Sciences or a related field is mandatory.**
• **Minimum 8\+ years of experience** in Centralized Monitoring (CM), clinical monitoring, or related clinical trial activities.
• **Hands\-on experience in site monitoring strategy and oversight**, including developing risk assessments and monitoring plans.
• **Hands\-on experience with centralized monitoring tools such as Spotfire, CluePoints, or equivalent platforms.**
• **Strong experience in Risk\-Based Quality Management (RBQM), Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).**
• **Practical experience in risk signal analysis, trend analysis, anomaly detection, and root cause analysis.**
• Experience in clinical trial monitoring, site management, data management, biostatistics, or related clinical research activities.
• Experience leading centralized monitoring activities, managing review cycles, and coordinating with cross\-functional teams.
• Strong understanding of clinical trial protocols, ICH\-GCP guidelines, regulatory requirements, and global SOPs.
• Experience in sponsor oversight, clinical trial risk assessment, and risk mitigation.
• Experience managing complex clinical trials involving multiple sites, countries, vendors, and stakeholders.
• Equivalent professional education and directly relevant experience may be considered where applicable.

### **Strong Communication Skills:**

• Demonstrates Accountability, Agility, and Intrapreneurship (AAI) in complex cross\-functional and matrix team environments.
• Strong written and verbal communication skills in English.
• Ability to communicate effectively with internal teams, functional management, sponsors, and clients.
• Demonstrates active listening, cultural awareness, and strong stakeholder management skills.
• Ability to align business strategies, project objectives, and operational activities.

### **Scientific and Operational Expertise:**

• Strong scientific, therapeutic, and operational knowledge of clinical trial planning and execution.
• Comprehensive understanding of site monitoring, centralized monitoring, and site management processes.
• Experience implementing risk\-based monitoring strategies across clinical studies.
• Ability to interpret clinical trial protocols, monitoring plans, and study documentation.
• Strong understanding of clinical trial complexity involving protocols, patients, sites, countries, and vendors.
• Ability to identify, investigate, and mitigate clinical trial risks through data analytics and monitoring oversight.

### **Leadership and Influence:**

• Demonstrates strong leadership skills in coordinating and overseeing cross\-functional teams.
• Ability to independently lead projects and manage monitoring activities.
• Experience setting priorities, managing timelines, and ensuring high\-quality deliverables.
• Ability to guide, mentor, and support junior team members.
• Strong decision\-making and problem\-solving skills in complex clinical trial environments.
• Ability to influence stakeholders and drive effective collaboration across teams.

### **Knowledge, Skills and Abilities:**

• Strong knowledge of **Centralized Monitoring (CM), Site Monitoring, and Risk\-Based Quality Management (RBQM)**.
• Hands\-on experience with **Spotfire, CluePoints, or similar centralized monitoring tools**.
• Strong understanding of **KRIs, QTLs, risk signal analysis, trend analysis, and anomaly detection**.
• Ability to perform complex data reviews, root cause analyses, and risk assessments.
• Strong analytical, numerical, and problem\-solving skills with attention to detail.
• Ability to identify trends and potential risks using clinical trial data and electronic study systems.
• Comprehensive understanding of clinical trial protocols, centralized monitoring plans, and functional study documentation.
• Ability to apply regulatory guidelines, global SOPs, and client requirements.
• Strong organizational and project management skills, including planning, prioritization, and workload management.
• Ability to independently manage multiple projects and coordinate activities across teams.
• Strong stakeholder management and cross\-functional collaboration skills.
• Ability to maintain confidentiality of clinical trial data and client information.
• Proven flexibility, adaptability, and accountability in changing project environments.
• Strong computer skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint).
• Ability to learn and effectively utilize clinical trial monitoring and data analytics systems.
• Ability to serve as a **Subject Matter Expert (SME)** and lead cross\-functional projects.