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.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Central Monitoring Operations Manager - FSP