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,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes.WearelookingforanexperiencedClinicalResearchManager(CRM)tojoinourOphthalmologyteamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries.Thisisafull-time,home-basedopportunityopentocandidateslocatedinPoland,Spain,orItalyAboutthisrole AspartofourOphthalmologyteam,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals.TheClinicalResearchManager(CRM)willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies,SOPs,ICH-GCPguidelines,regulatoryrequirements,andcontractualobligations.YouwillworkcloselywithProjectManagers,ClinicalResearchAssociates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards. KeyResponsibilities Manageday-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. Qualifications Bachelor'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 inItaly Salary: €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. WhatWeOffer Weprovideacompetitivecompensationpackage,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.#TogetherWeMakeADifferenceOriginally posted on Himalayas