Monitoring Oversight Central Monitor

Location
Tarrytown, New York
Posted
May 01, 2018
Ref
13212BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Oversight Central Monitor is responsible for centrally evaluating investigative site and CRO CRA performance within a study by reviewing defined performance indicators. The Oversight Central Monitor, in conjunction with the study team, identifies investigative sites and CRO CRAs with potential performance issues that could require an oversight visit. The focus is on studies where the monitoring component is outsourced to a CRO.

Duties:

• Act as facilitator for the implementation and training of CRO Monitoring Oversight within the study teams
• Ensure the application, reports, and other listings are setup for each required study to conduct the comprehensive data assessment
• Conduct a periodic comprehensive assessment of investigative site/CRA performance as described in the CRO Monitoring Oversight Plan with the objective of identifying sites that potentially require an oversight visit
• Understand how to use data aggregation/visualization technology to evaluate performance and the source data used by the system for each of the Key Performance Indicators (KPIs).
• Review KPIs from data aggregation tools and other metric reports during study conduct to identify investigative sites and/or CRAs displaying outlier (higher risk) data
• Understand the relationships between each KPI and any supporting data to assess trends within a site
• Periodically review aggregated data from oversight visit findings to determine trends across sites using visualization tools that display multiple data views (e.g., by region; by country)
• Consolidate results of the comprehensive assessment and provide to the study management team.
• Conduct periodic comprehensive assessment review meetings with the study teams to solicit additional input on investigative sites/CRAs and identify sites requiring an oversight visit
• Document the output from the comprehensive assessment review meetings and track decisions/actions to closure
• Follow-up on any required actions to support study monitoring oversight
• Participate in oversight team meetings and contribute to the continued improvement of processes and supporting technology

Requirements:
Bachelor's degree and minimum X years of relevant industry experience. Site monitoring or data management experience a plus.

• 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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 13212BR