Senior Manager Central Monitoring

Regeneron Pharmaceuticals

7d

About The Position

The Senior Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or complex trials or program level analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a Comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Senior Manager, Central Monitoring will be responsible for supporting a number of studies within a therapy area and program-level. They will work closely with other Central Monitors to ensure effective identification, conduct and reporting of central monitoring activities in support of sponsor oversight obligations. The role will lead, contribute, and drive continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities. A typical day in this role looks like: Central Monitoring Reviews Responsible for development and authoring activities of the Central Monitoring Plan Participate in the Quality Risk and Control Tracker (QRACT) development Present at the CRO kick-off meeting Work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies. Conduct & Communicate Study-level and Program-Level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools Interpret the relationships between each Key Performance Indicator/metric and any supporting data to critically assess trends within a site/study Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralized monitoring activities and/or investigator sites potentially requiring sponsor intervention. Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions. Document the output from the Central Monitoring Review meetings and track decisions/actions to closure Access, review and complete applicable tracking and reporting tools when necessary eg. CTMS/ODR/etc. Risk-Based Quality Management Methodology Define strategies, interpret data, and provide insights for Central Monitoring under the Risk-Based Quality Management (RBQM) operating model at functional and partnership levels. Present at periodic study and program-level Quality Risk Review meetings with the study team SME Act as a subject matter expert for the implementation and execution of Central Monitoring within the study teams Represent Central Monitoring with audit and inspection preparation and conduct if applicable Functional Oversight (Depends on whether CM in-house or not) Partner with outsourcing management and counterparts at CROs to align on monitoring and central monitoring strategy, standards, risk based monitoring strategy, and input into the central monitoring documents Provide oversight of CRO partner central monitoring activities ensuring the CRO is executing per the Partnership Operations Manual Continuous Improvement Critically evaluate the availability, quality and output of integrated data, metrics and reports to ensure they continue to meet the needs in support of the Central Monitoring review processes Represent Central Monitoring in process improvement initiatives, and participate in functional strategic planning Assess and evaluate the Central Monitoring Process including sensitivity of detection methods, availability of new technologies, required enhancements to process to further refine where necessary Assign and delegate appropriate tasks to Central Monitoring Associate Manager & Central Monitoring Managers Line management and performance management; Tasks include and are not limited to: raising/setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. May require 25% travel

Requirements

• Proficiency and experience with CluePoint or similar RQBM system for Central Monitoring
• Problem solving abilities, troubleshooting and resourcefulness
• Analytical problem-solving experience
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Understands current and possible future business trends and information
• Demonstrates writing skills to deliver messages effectively so messages are clearly understood
• Proficiency in Microsoft Office applications
• A minimum of a Bachelor’s degree is required
• At least 8 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct Central Monitoring experience.

Nice To Haves

• Site monitoring or data management experience a plus.

Responsibilities

• Responsible for development and authoring activities of the Central Monitoring Plan
• Participate in the Quality Risk and Control Tracker (QRACT) development
• Present at the CRO kick-off meeting
• Work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies.
• Conduct & Communicate Study-level and Program-Level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools
• Interpret the relationships between each Key Performance Indicator/metric and any supporting data to critically assess trends within a site/study
• Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralized monitoring activities and/or investigator sites potentially requiring sponsor intervention.
• Support study teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions.
• Document the output from the Central Monitoring Review meetings and track decisions/actions to closure
• Access, review and complete applicable tracking and reporting tools when necessary eg. CTMS/ODR/etc.
• Define strategies, interpret data, and provide insights for Central Monitoring under the Risk-Based Quality Management (RBQM) operating model at functional and partnership levels.
• Present at periodic study and program-level Quality Risk Review meetings with the study team SME
• Act as a subject matter expert for the implementation and execution of Central Monitoring within the study teams
• Represent Central Monitoring with audit and inspection preparation and conduct if applicable
• Partner with outsourcing management and counterparts at CROs to align on monitoring and central monitoring strategy, standards, risk based monitoring strategy, and input into the central monitoring documents
• Provide oversight of CRO partner central monitoring activities ensuring the CRO is executing per the Partnership Operations Manual
• Critically evaluate the availability, quality and output of integrated data, metrics and reports to ensure they continue to meet the needs in support of the Central Monitoring review processes
• Represent Central Monitoring in process improvement initiatives, and participate in functional strategic planning
• Assess and evaluate the Central Monitoring Process including sensitivity of detection methods, availability of new technologies, required enhancements to process to further refine where necessary
• Assign and delegate appropriate tasks to Central Monitoring Associate Manager & Central Monitoring Managers
• Line management and performance management; Tasks include and are not limited to: raising/setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
• For other countries’ specific benefits, please speak to your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees