Manager Central Monitoring Data Analysis

Role & responsibilities

• Act as a subject-matter expert for the configuration, implementation, and execution of Central Monitoring RBQM platforms across studies.
• Maintain Central Monitoring Key Risk Indicator and Quality Tolerance Limit libraries to ensure consistent deployment across studies and alignment with regulatory requirements.
• Configure studies within an RBQM platform by partnering with functional and cross-functional stakeholders to develop Central Monitoring configuration specifications.
• Provide operational expertise, training, and guidance, serving as an escalation point for issues related to the Central Monitoring RBQM platform.
• Conduct central monitoring reviews as required, including recurring data refreshes and troubleshooting execution errors in support of Study Central Monitors.
• Apply programming expertise to support Central Monitoring data analysis, automation, reporting, and system integration.
• Interpret and present Key Risk Indicator and Key Performance Indicator data to support informed decision-making.
• Contribute to the continuous improvement and standardization of technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
• Represent Central Monitoring in process-improvement initiatives and collaborate effectively with internal and external stakeholders.
• Oversee multiple studies within an assigned therapeutic area, as applicable, and contribute to innovation in central monitoring capabilities.
• Travel up to 25%, as required.

Preferred candidate profile

• At least 7 years of relevant biotechnology or pharmaceutical industry experience. Experience in Central Monitoring, site monitoring, or data management is preferred.
• A minimum of 2 years of direct experience with RBQM systems.
• Technical expertise in database design, system configuration, and report development, with experience managing RBQM 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.
• Strong analytical, critical-thinking, and problem-solving skills, including experience troubleshooting data refreshes and resolving execution errors in analytical systems.
• Working knowledge of the clinical drug-development process, including ICH and GCP guidelines and applicable regulatory requirements.
• Experience with clinical databases, electronic data-capture systems, quality-control processes, and auditing procedures.
• The skills for mathematical concepts, statistical methodologies, and data analytics, with the ability to interpret KRIs and KPIs.
• The ability to identify and interpret current and emerging business trends and apply them to centralized monitoring practices.
• Effective interpersonal, verbal, and written communication skills, with the ability to convey sophisticated technical and analytical insights clearly and concisely.
• The ability to collaborate across cross-functional teams and build effective internal and external relationships.
• Proficiency in Microsoft Office applications, including sophisticated Excel skills for data manipulation and reporting.
• Experience using CluePoints or a similar centralized monitoring and risk-based quality management solution is preferred