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.

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