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
This role may be for you if you have:
- 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
In order to be considered qualified for this role, a minimum of a Bachelor’s degree is required and at least 8 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct Central Monitoring experience. Site monitoring or data management experience a plus.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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