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The Manager, Data Analysis, is responsible for overseeing centralized monitoring activities for global and/or complex clinical trials, ensuring the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This role involves configuring studies within 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 well as conducting comprehensive reviews of supplemental operational data, trends, and issues. Proficiency in programming languages such as R, SQL, or SAS will be essential for creating custom analyses, automating workflows, and integrating data systems. As an integral member of the Central Monitoring team, the Manager will deliver actionable insights to drive decision-making and optimize trial performance. Additionally, the Manager will oversee multiple studies within a designated therapy area, lead 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 Responsibility:
Act 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 Quality Tolerance Limit Libraries within Central Monitoring RBQM system to ensure standard deployment consistency and alignment with regulatory requirements
Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system
Provide operational expertise, training, and guidance as a point of escalation for Central Monitoring issues related 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
Requirements:
At least 4 years of relevant biotechnology/pharmaceutical industry experience
Minimum 2 years with direct RBQM systems experience
Technical expertise in database design, system configuration, and report development, with experience in managing Risk-Based Quality Management (RBQM) systems or similar platforms
Proficiency in programming languages such as Python, R, SQL, or SAS, with the ability to develop 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 focus on interpreting Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs)
Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures
Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting
Nice to have:
Central Monitoring, site monitoring or data management experience a plus
Preferred: Experience using CluePoints or similar centralized monitoring and risk-based quality management solutions