Clinical Research Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7g0vbj

TFSHealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.JoinOurTeamasaClinicalResearchManager(CRM) - home based in Poland, Spain or Italy. AtTFSHealthScience,(CRM),home-basedopportunityopentocandidateslocatedinPoland,Spain,orItalyAboutthisroleAspartofourOphthalmologyteam,(CRM)willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies,SOPs,ICH-GCPguidelines,regulatoryrequirements,,ClinicalResearchAssociates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards.KeyResponsibilitiesManageday-to-dayclinicaloperationsactivitiesforassignedprojectsinaccordancewithstudyprotocols,contracts,SOPs,ICH-GCPguidelines,,coach,andsupportCRAs,ensuringproject-specifictrainingrequirementsarecompletedanddocumented.Overseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams.Developandimplementstudymonitoringplans,sitetrainingplans,,,,datalistings,(TMF)quality,,site,,training,andhandoveractivities.Contributetostudycommunications,newsletters,,revenuerecognition,,workloadplanning,andperformancediscussions.Supportbusinessdevelopmentinitiatives,proposals,budgetdevelopment,andbiddefenseactivitiesasrequired.QualificationsBachelor'sdegreeinLifeSciences,ClinicalResearch,Nursing,Pharmacy,,includingsignificantexperienceasaClinicalResearchAssociate(CRA)withindependenton-sitemonitoringresponsibilities.Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study.Experiencecoordinatingoroverseeingclinicaltrialoperationsatastudy,country,orregionallevel.Strongunderstandingofclinicaltrialprocessesfromstart-upthroughcloseout.In-depthknowledgeofGoodClinicalPractice(ICH-GCP),regulatoryre

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7g0vbj