Regeneron Pharmaceuticals Jobs

A Manager, Central Monitor TEMP 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 Central Monitor will be responsible for supporting a number of studies within a therapy area. The Central Monitor will work closely with the Monitoring Oversight Associate and the Oversight CRAs to ensure effective identification, conduct and reporting of supervising 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.

A typical day might include the following:

• 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 coordinated 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.

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

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

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

• Ensure assigned actions and detailed follow-up to support study supervising oversight

• Support any ad-hoc requests for central review of study/site data related to Supervising 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 improvements to process to further refine where vital

This role might be for you if:

• You have problem solving abilities, troubleshooting and resourcefulness

• You have working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations

• You have effective communication and interpersonal skills; ability to build relationships internally and externally

• You understand current and possible future business trends and information

• You have proven writing skills to deliver messages optimally so messages are clearly understood

• Proficiency in Microsoft Office applications

To be considered for this opportunity, you must have at minimum a Bachelor’s degree and 5+ years of relevant industry experience, with 2 of those years working as a Central Monitor. Experience and proficiency in Cluepoints as a Data Analyst, site monitoring experience, and/or data management experience is a plus. This is a fully remote role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 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.