Oversight Central Monitor
Regeneron Pharmaceuticals Inc

Job Info

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The Oversight Central Monitor is accountable for conducting centralized analytical data review of operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies outsourced to a CRO. The reviews include interpretation of Key Performance Indicator 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 Oversight Central Monitor will be responsible for supporting a number of studies within a therapy area. The Oversight Central Monitor will work closely with the Monitoring Oversight Associate and the Oversight CRAs to ensure effective identification, conduct and reporting of monitoring oversight activities in support of sponsor oversight obligations. The role will contribute and drive continued process improvement and innovation activities, and may assume line management responsibilities.

In this role, a typical day may include:

• Acting as SME for the implementation and training of CRO Monitoring Oversight within the study teams
  
• Critically evaluating the availability, quality and output of integrated data, metrics and reports to ensure they continue to meet the needs of the Comprehensive data review process
  
• Reviewing, interpreting and reporting data as an integral part of the Clinical Study Team in support of identifying investigator sites potentially requiring a sponsor Monitoring Oversight on-site visit or other sponsor intervention
  
• Conducting a periodic study-level Comprehensive Assessment for assigned studies in a given therapy area using data analysis tools.
  
• Detailing the output from the Comprehensive Assessment review meetings and tracking decisions/actions to closure
  
• Accessing, reviewing and completing applicable tracking and reporting tools when vital e.g. CTMS/ODR
  
• Attending and presenting at periodic study Quality Risk Review meetings with the study team and CRO vendor
  
• Ensuring assigned actions and documented follow-up to support study monitoring oversight
  
• Supporting any ad-hoc requests for central review of study/site data related to Monitoring Oversight
  
• Actively participating in process improvement initiatives as a Monitoring function representative
  
• Continuing to assess and evaluate the CRO Monitoring Oversight process including sensitivity of detection methods, availability of new technologies, required improvements to process to further refine where necessary
  
• Supporting clinical study teams with audit and inspection preparation and conduct if applicable
  
• Assigning and delegating appropriate tasks to the Monitoring Oversight Associate
  
• May require 25% travel
  

This role might be for you if:

• You are analytical, inventive leader with a proven track record determining root cause and developing resolution
  
• You have the ability to interpret the relationships between metrics and any supporting data to critically assess trends within a site/study
  
• You have solid understanding of clinical drug development process as well as ICH, GCP guidelines, and regulations
  
• You have proven writing skills to deliver messages effectively so messages are clearly understood
  
• To be considered, you'll need a Bachelor's degree and minimum 5 years of relevant industry experience. Proficiency in Microsoft Office applications is necessary. Site monitoring and/or data management experience is a plus.
  

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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