Manager Central Monitoring

Buildourfuturetogether:

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing,developing,andcommercializingmedicinesthatchangelivesforthosewithseriousdiseases.Indoingso,wearepioneeringinnovativeapproachestoscience,manufacturing,andcommercialization,aswellasredefiningourunderstandingofhealth.

AtRegeneron,weusescienceandinnovationtodeveloplife-changingmedicinesforpeoplewithseriousdiseases.WeareseekingaManager,CentralMonitoring,DataAnalysis to join our Global Clinical Trial Services team. In this role, you will oversee centralized monitoring activities for global and complex clinical trials and support the configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) platforms. You will leverage your programming and analytical expertise to create customized analyses, automate workflows, integrate data systems, and deliver actionable insights that support informed decision-making and optimizeclinicaltrialperformance.Youmayalsooverseemultiplestudieswithinanassignedtherapeuticarea,leadprocess-improvementinitiatives,andcollaboratewithcross-functionalteamsandindustrypartnerstoadvancecentralmonitoringcapabilities.

When&where:

Hyderabad, India (hybrid)

Discoveryourrole:

• Actasasubject-matterexpertfortheconfiguration,implementation,andexecutionofCentralMonitoringRBQMplatformsacrossstudies.

• MaintainRegeneronCentralMonitoringKeyRiskIndicatorandQualityToleranceLimitlibrariestoensureconsistentdeploymentacrossstudiesandalignmentwithregulatoryrequirements.

• ConfigurestudieswithinanRBQMplatformbypartneringwithfunctionalandcross-functionalstakeholderstodevelopCentralMonitoringconfigurationspecifications.

• Provideoperationalexpertise,training,andguidance,servingasanescalationpointforissuesrelatedtotheCentralMonitoringRBQMplatform.

• Conductcentralmonitoringreviewsasrequired,includingrecurringdatarefreshesandtroubleshootingexecutionerrorsinsupportofStudyCentralMonitors.

• ApplyprogrammingexpertisetosupportCentralMonitoringdataanalysis,automation,reporting,andsystemintegration.

• InterpretandpresentKeyRiskIndicatorandKeyPerformanceIndicatordatatosupportinformeddecision-making.

• Contributetothecontinuousimprovementandstandardizationoftechnologies,systems,processes,andtrainingmaterialsthatsupportCentralMonitoringandRBQM.

• RepresentCentralMonitoringinprocess-improvementinitiativesandcollaborateeffectivelywithinternalandexternalstakeholders.

• Overseemultiplestudieswithinanassignedtherapeuticarea,asapplicable,andcontributetoinnovationincentralmonitoringcapabilities.

• Travelupto25%,asrequired.

Thisrolerequires:

• Atleast7yearsofrelevantbiotechnologyorpharmaceuticalindustryexperience.ExperienceinCentralMonitoring,sitemonitoring,ordatamanagementispreferred.

• Aminimumof2yearsofdirectexperiencewithRBQMsystems.

• Technicalexpertiseindatabasedesign,systemconfiguration,andreportdevelopment,withexperiencemanagingRBQMorsimilarplatforms.

• ProficiencyinprogramminglanguagessuchasPython,R,SQL,orSAS,withtheabilitytodevelopscriptsfordataanalysis,automation,andsystemintegration.

• Stronganalytical,critical-thinking,andproblem-solvingskills,includingexperiencetroubleshootingdatarefreshesandresolvingexecutionerrorsinanalyticalsystems.

• Workingknowledgeoftheclinicaldrug-developmentprocess,includingICHandGCPguidelinesandapplicableregulatoryrequirements.

• Experiencewithclinicaldatabases,electronicdata-capturesystems,quality-controlprocesses,andauditingprocedures.

• The skills formathematicalconcepts,statisticalmethodologies,anddataanalytics,withtheabilitytointerpretKRIsandKPIs.

• Theabilitytoidentifyandinterpretcurrentandemergingbusinesstrendsandapplythemtocentralizedmonitoringpractices.

• Effectiveinterpersonal,verbal,andwrittencommunicationskills,withtheabilitytoconveysophisticatedtechnicalandanalyticalinsightsclearlyandconcisely.

• Theabilitytocollaborateacrosscross-functionalteamsandbuildeffectiveinternalandexternalrelationships.

• ProficiencyinMicrosoftOfficeapplications,includingsophisticatedExcelskillsfordatamanipulationandreporting.

• ExperienceusingCluePointsorasimilarcentralizedmonitoringandrisk-basedqualitymanagementsolutionispreferred

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visithttps://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.