Central Monitoring Operations Manager – FSP

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🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 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 effective risk identification, trend analysis, and signal detection to support trial quality, patient safety, and data integrity • Author risk assessments and monitoring plans for site monitoring strategy and oversight • Provide site monitoring expertise to trial teams 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 standards • Safeguard patient safety, data integrity, and trial outcomes through monitoring oversight • Lead centralized monitoring activities, including development of 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 budget support • Coordinate with internal teams, sponsors, and cross-functional stakeholders • Prepare and deliver 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 • Serve as 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 Spotfire, CluePoints, or equivalent centralized monitoring 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 • Ability to communicate effectively with internal teams, functional management, sponsors, and clients • Active listening, cultural awareness, and stakeholder management skills • Ability to align business strategies, project objectives, and operational activities • 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 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 • 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 • 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

🏖️ Benefits

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

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