Central Monitoring Operations Manager – FSP

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🔥 7 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 by setting functional plans, monitoring tools, and data review cycles • Provide expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight • Author risk assessments and monitoring plans and oversee site monitoring strategy • Ensure sponsor oversight, trend analysis, signal detection, trial quality, and delivery • Lead implementation of monitoring and oversight approaches for trial teams • Oversee planning, execution, and issue management of site monitoring activities across R/OPUs • Ensure compliance with protocols, ICH-GCP, regulatory requirements, and inspection readiness • Safeguard patient safety, data integrity, and trial outcomes • Develop study-specific centralized monitoring 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 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, 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 • Ability to communicate effectively with internal teams, functional management, sponsors, and clients • Active listening, cultural awareness, and stakeholder management skills • 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 leadership, decision-making, problem-solving, organizational, and project management skills • Ability to independently lead projects and manage monitoring activities • Ability to guide, mentor, and support junior team members • Strong knowledge of Centralized Monitoring, Site Monitoring, and RBQM • Ability to perform complex data reviews, root cause analyses, and risk assessments • Strong analytical and numerical skills with attention to detail • Ability to apply regulatory guidelines, global SOPs, and client requirements • Ability to manage multiple projects and coordinate activities across teams • Ability to maintain confidentiality of clinical trial data and client information • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint • Ability to learn and effectively use clinical trial monitoring and data analytics systems • Ability to serve as a Subject Matter Expert and lead cross-functional projects

🏖️ Benefits

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

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