Central Monitoring Operations Manager - FSP

Thermo Fisher ScientificRemote, IndiaremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

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-f

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