Manager Monitoring Oversight

Location
Tarrytown, New York, US
Posted
Oct 05, 2018
Ref
14029BR
Required Education
Associate Degree
Position Type
Full time
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 Manager Monitoring Oversight 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 (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 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.

Duties:

• Act as a subject matter expert for the implementation and training of CRO Monitoring Oversight within the study teams

• 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 Comprehensive data review process

• Ability to 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 investigator sites potentially requiring a sponsor Monitoring Oversight on-site visit or other sponsor intervention

• Conduct a periodic study-level Comprehensive Assessment for assigned studies in a given therapy area using data analysis tools.

• Document the output from the Comprehensive Assessment review meetings and track decisions/actions to closure

• Access, review and complete applicable tracking and reporting tools when necessary eg. CTMS/ODR

• Attend and present at periodic study Quality Risk Review meetings with the study team and CRO vendor

• Ensure assigned actions and documented follow-up to support study monitoring oversight

• Support any ad-hoc requests for central review of study/site data related to Monitoring Oversight

• Actively participate in process improvement initiatives as a Monitoring function representative

• Continue to assess and evaluate the CRO Monitoring Oversight process including sensitivity of
detection methods, availability of new technologies, required enhancements to process to further refine where necessary

• Support clinical study teams with audit and inspection preparation and conduct if applicable

• Assign and delegate appropriate tasks to the Monitoring Oversight Associate

Requirements:

• 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.

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