Clinical Research Manager

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,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. AsaglobalCROwiththeultimategoalofensuri