Central Monitoring Operations Manager

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Act as a Subject Matter Expert and interdepartmental and client liaison for data analytics activities. • Develop tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks. • Lead projects, including setting up functional plans, monitoring tools, and data review cycles. • Provide expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight. • Ensure risk identification, trend analysis, and signal detection support trial quality, patient safety, and data integrity. • Author risk assessments and monitoring plans and oversee site monitoring strategy. • Provide site monitoring expertise and lead 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 inspection readiness. • Lead centralized monitoring activities, including study-specific tools, monitoring plans, and data review processes. • Perform complex data reviews, risk signal analysis, trend analysis, and root cause analysis. • Monitor KRIs, QTLs, and RBQM activities. • Manage review timelines, analysis assignments, project deliverables, and support budget management. • Coordinate with internal teams, sponsors, and cross-functional stakeholders. • Prepare centralized monitoring reports and lead monitoring review meetings. • Participate in cross-functional risk assessment meetings and contribute to risk planning and mitigation strategies. • Develop and enhance monitoring tools, dashboards, and analytical processes. • Provide training, mentoring, and guidance to junior team members. • Act as a project lead, development specialist, or both, depending on project requirements.

🎯 Requirements

• 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 written and verbal communication skills in English. • 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. • Strong leadership, decision-making, problem-solving, analytical, numerical, organizational, project management, stakeholder management, and cross-functional collaboration skills. • Strong knowledge of Centralized Monitoring (CM), Site Monitoring, and Risk-Based Quality Management (RBQM). • 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. • Ability to identify trends and potential risks using clinical trial data and electronic study systems. • Ability to apply regulatory guidelines, global SOPs, and client requirements. • Ability to independently manage multiple projects and coordinate activities across teams. • Ability to maintain confidentiality of clinical trial data and client information. • 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.

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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