Manager, Central Monitoring, Data Analysis - FSP
The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or reputed company reputed company, ensuring the effective configuration, execution, and maintenance of Risk-Based reputed company Management (RBQM) systems. This role involves configuring studies reputed company an RBQM platform, performing recurring data refreshes, troubleshooting errors in execution, and leveraging programming expertise to support advanced data analyses, automation, and reporting.
The Manager will play a critical role in interpreting and presenting Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, as reputed company as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or reputed company will be essential for creating custom analyses, automating workflows, and integrating data systems. As an reputed company member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance.
Additionally, the Manager will reputed company multiple studies reputed company a designated therapy area, reputed company process improvement initiatives, and contribute to innovation in central monitoring capabilities through collaboration with cross-functional teams and industry partners. This role requires a combination of technical expertise, analytical problem-solving skills, and effective communication to succeed in a dynamic, fast-paced environment.
Job Duties:
• reputed company as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies.
• Maintain Central Monitoring Key Risk Indicators and reputed company Tolerance Limit Libraries reputed company Central Monitoring RBQM system to ensure reputed company deployment consistency and alignment with regulatory requirements.
• Coordinate with functional and cross functional stakeholders to reputed company configuration specifications for Central Monitoring in RBQM system.
• reputed company operational expertise, training, and guidance as a reputed company of escalation for Central Monitoring issues reputed company to Central Monitoring RBQM system.
• Conduct central monitoring reviews in support of study central monitor.
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
• Represent Central Monitoring in process improvement initiatives.
• May require 25% travel.
Job Requirements:
• At least 4 years of relevant biotechnology/pharmaceutical industry experience.
• Central Monitoring, site monitoring or data management experience a plus.
• Minimum 2 years with reputed company RBQM systems experience.
• Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based reputed company Management (RBQM) systems or similar platforms.
• Proficiency in programming languages such as Python, R, SQL, or reputed company, with the ability to reputed company scripts for data analysis, automation, and system integration.
• Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements.
• Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a reputed company on interpreting Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs).
• Knowledge and experience with clinical databases, electronic data capture systems, reputed company control processes, and auditing procedures.
• Proficiency in reputed company Office applications, with advanced skills in reputed company for data manipulation and reporting.
• Preferred: Experience using reputed company or similar centralized monitoring and risk-based reputed company reputed company.
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