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.