TFSHealthScience is a leading general 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,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes.WearelookingforanexperiencedClinicalResearchManager(CRM)tojoinourOphthalmologyteamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries.Thisisafull-time,home-basedopportunityopentocandidateslocatedinPoland,Spain,orItalyAboutthisroleAspartofourOphthalmologyteam,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals.TheClinicalResearchManager(CRM)willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies,SOPs,ICH-GCPguidelines,regulatoryrequirements,andcontractualobligations.YouwillworkcloselywithProjectManagers,ClinicalResearchAssociates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards.KeyResponsibilitiesManageday-to-dayclinicaloperationsactivitiesforassignedprojectsinaccordancewithstudyprotocols,contracts,SOPs,ICH-GCPguidelines,andapplicableregulations.Serveastheprimarysponsorcontactforoperationalproject-specificissuesandstudydeliverables.Lead,coach,andsupportCRAs,ensuringproject-specifictrainingrequirementsarecompletedanddocumented.Overseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams.Developandimplementstudymonitoringplans,sitetrainingplans,andverificationinitiatives.Coordinateinvestigatormeetingsandsupportsiteandcountry-levelstudyreportingactivities.Ensurestudyprocessesandoperationalstrategiesremainpracticalandeffectivefromfeasibilitythroughstudycloseout.ActastheprimarypointofcontactforCRAsandmonitoringteams,providingguidanceonsite-relatedchallengesandescalations.Supportrecruitmentandmonitoringstrategiestooptimizestudyperformance.Conductco-monitoringvisitstoensurequalityoversightandconsistencyacrossmonitoringactivities.Reviewandapprovemonitoringvisitreports,ensuringtimelyresolutionandescalationofidentifiedissues.Reviewmonitoringschedulesandsitevisitcalendarstoensurecompliancewithmonitoringplans.Monitorprotocoldeviations,datalistings,andqualitymetricstoproactivelyidentifyrisksandimplementmitigationstrategies.LeadstudyteammeetingsandprovideregularupdatestoProjectManagersregardingsiteandcountryperformance.EnsureaccuratemaintenanceofstudydocumentationandTrialMasterFile(TMF)quality,whendelegated.ReviewCTMSdatatoensuretimelyandaccuraterecordingofcountry,site,andsubjectinformation.Supportinvestigatorpaymenttrackingandapprovalprocesseswhendelegated.CollaboratewithProjectManagersonCRAonboarding,training,andhandoveractivities.Contributetostudycommunications,newsletters,andoperationalupdates.Provideprojectinsightsrelatedtoresourceutilization,revenuerecognition,andforecastingactivities.ParticipateinInvestigatorMeetingsandpresentmonitoringrequirementsandexpectationswhenrequired.Promoteproactiveissueresolutionandasolution-orientedapproachacrossstudyteams.PartnerwithCRALineManagersregardingstudyassignments,workloadplanning,andperformancediscussions.Supportbusinessdevelopmentinitiatives,proposals,budgetdevelopment,andbiddefenseactivitiesasrequired.QualificationsBachelor'sdegreeinLifeSciences,ClinicalResearch,Nursing,Pharmacy,oranotherhealth-relatedfield.Minimumof5yearsofclinicalresearchexperience,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),regulatoryrequirements,andclinicalresearchstandards.For 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.You'llbejoiningateamthatvaluescollaboration,innovation,andmakingadifferenceinthelivesofpatients.AtTFSHealthScience,you'llhavetheopportunitytoworkondiverseandimpactfulclinicaldevelopmentprogramswhilecollaboratingwithtalentedcolleaguesacrosstheglobe.ABitMoreAboutUsOurjourneybeganover25yearsagoinSweden,inthecityofLund.AsaglobalCROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions.Wecurrentlyoperatein17countriesacrossEurope,NorthAmerica,AsiaPacific,andtheMiddleEast.OurcorevaluesofTrust,Quality,Flexibility,andPassionarewhatmakeTFSHealthSciencethesuccessfulcompanyitistoday.Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.#TogetherWeMakeADifference

📌 Clinical Research Manager (Barcelona)
🏢 Trial Form Support
📍 Barcelona