Clinical Research Manager
Pubblicato il 21-10-2026 - Trial Form Support in Italia
pTFSHealthScience 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. /p pJoinOurTeamasaClinicalResearchManager(CRM) - home based in Poland, Spain or Italy. AtTFSHealthScience,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes. /p pWearelookingforanexperiencedClinicalResearchManager(CRM)tojoinourOphthalmologyteamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries. /p pThisisafull-time,home-basedopportunityopentocandidateslocatedinPoland,Spain,orItalyAboutthisroleAspartofourOphthalmologyteam,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals. /p pTheClinicalResearchManager(CRM)willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies,SOPs,ICH-GCPguidelines,regulatoryrequirements,andcontractualobligations. /p pYouwillworkcloselywithProjectManagers,ClinicalResearchAssociates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards. /p pKeyResponsibilitiesManageday-to-dayclinicaloperationsactivitiesforassignedprojectsinaccordancewithstudyprotocols,contracts,SOPs,ICH-GCPguidelines,andapplicableregulations. /p pServeastheprimarysponsorcontactforoperationalproject-specificissuesandstudydeliverables. /p pLead,coach,andsupportCRAs,ensuringproject-specifictrainingrequirementsarecompletedanddocumented. /p pOverseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams. /p pDevelopandimplementstudymonitoringplans,sitetrainingplans,andverificationinitiatives. /p pCoordinateinvestigatormeetingsandsupportsiteandcountry-levelstudyreportingactivities.
/p pEnsurestudyprocessesandoperationalstrategiesremainpracticalandeffectivefromfeasibilitythroughstudycloseout. /p pActastheprimarypointofcontactforCRAsandmonitoringteams,providingguidanceonsite-relatedchallengesandescalations. /p pSupportrecruitmentandmonitoringstrategiestooptimizestudyperformance. /p pConductco-monitoringvisitstoensurequalityoversightandconsistencyacrossmonitoringactivities. /p pReviewandapprovemonitoringvisitreports,ensuringtimelyresolutionandescalationofidentifiedissues. /p pReviewmonitoringschedulesandsitevisitcalendarstoensurecompliancewithmonitoringplans. /p pMonitorprotocoldeviations,datalistings,andqualitymetricstoproactivelyidentifyrisksandimplementmitigationstrategies. /p pLeadstudyteammeetingsandprovideregularupdatestoProjectManagersregardingsiteandcountryperformance. /p pEnsureaccuratemaintenanceofstudydocumentationandTrialMasterFile(TMF)quality,whendelegated. /p pReviewCTMSdatatoensuretimelyandaccuraterecordingofcountry,site,andsubjectinformation. /p pSupportinvestigatorpaymenttrackingandapprovalprocesseswhendelegated. /p pCollaboratewithProjectManagersonCRAonboarding,training,andhandoveractivities. /p pContributetostudycommunications,newsletters,andoperationalupdates. /p pProvideprojectinsightsrelatedtoresourceutilization,revenuerecognition,andforecastingactivities. /p pParticipateinInvestigatorMeetingsandpresentmonitoringrequirementsandexpectationswhenrequired. /p pPromoteproactiveissueresolutionandasolution-orientedapproachacrossstudyteams. /p pPartnerwithCRALineManagersregardingstudyassignments,workloadplanning,andperformancediscussions.
/p pSupportbusinessdevelopmentinitiatives,proposals,budgetdevelopment,andbiddefenseactivitiesasrequired. /p pQualificationsBachelor'sdegreeinLifeSciences,ClinicalResearch,Nursing,Pharmacy,oranotherhealth-relatedfield. /p pMinimumof5yearsofclinicalresearchexperience,includingsignificantexperienceasaClinicalResearchAssociate(CRA)withindependenton-sitemonitoringresponsibilities. /p pMinimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study. /p pExperiencecoordinatingoroverseeingclinicaltrialoperationsatastudy,country,orregionallevel. /p pStrongunderstandingofclinicaltrialprocessesfromstart-upthroughcloseout. /p pIn-depthknowledgeofGoodClinicalPractice(ICH-GCP),regulatoryrequirements,andclinicalresearchstandards. /p pFor candidates based in ItalySalary: 63,000 – 65,000 gross/year, in line with CCNL Terziario-Servizi (Level III), plus benefits (lunch vouchers, health insurance, pension, and car allowance where applicable). We welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.WhatWeOfferWeprovideacompetitivecompensationpackage,comprehensivebenefits,andtheopportunityforpersonalandprofessionalgrowthinarewardingenvironment. /p pYou'llbejoiningateamthatvaluescollaboration,innovation,andmakingadifferenceinthelivesofpatients. /p pAtTFSHealthScience,you'llhavetheopportunitytoworkondiverseandimpactfulclinicaldevelopmentprogramswhilecollaboratingwithtalentedcolleaguesacrosstheglobe. ABitMoreAboutUsOurjourneybeganover25yearsagoinSweden,inthecityofLund. /p pAsaglobalCROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions. /p pWecurrentlyoperatein17countriesacrossEurope,NorthAmerica,AsiaPacific,andtheMiddleEast. /p pOurcorevaluesofTrust,Quality,Flexibility,andPassionarewhatmakeTFSHealthSciencethesuccessfulcompanyitistoday. /p pThesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.#TogetherWeMakeADifference /p #J-18808-Ljbffr