TFSHealth Science 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. Join Our Teamasa Clinical Research Manager(CRM) - home based in Poland, Spain or Italy. At TFSHealth Science,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes. Wearelookingforanexperienced Clinical Research Manager(CRM)tojoinour Ophthalmologyteamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries. Thisisafull-time,home-basedopportunityopentocandidateslocatedin Poland, Spain,or Italy Aboutthisrole Aspartofour Ophthalmologyteam,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals. The Clinical Research Manager(CRM)willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies, SOPs, ICH-GCPguidelines,regulatoryrequirements,andcontractualobligations. Youwillworkcloselywith Project Managers, Clinical Research Associates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards. Key Responsibilities Manageday-to-dayclinicaloperationsactivitiesforassignedprojectsinaccordancewithstudyprotocols,contracts, SOPs, ICH-GCPguidelines,andapplicableregulations. Serveastheprimarysponsorcontactforoperationalproject-specificissuesandstudydeliverables. Lead,coach,andsupport CRAs,ensuringproject-specifictrainingrequirementsarecompletedanddocumented. Overseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams. Developandimplementstudymonitoringplans,sitetrainingplans,andverificationinitiatives. Coordinateinvestigatormeetingsandsupportsiteandcountry-levelstudyreportingactivities.



Ensurestudyprocessesandoperationalstrategiesremainpracticalandeffectivefromfeasibilitythroughstudycloseout. Actastheprimarypointofcontactfor CRAsandmonitoringteams,providingguidanceonsite-relatedchallengesandescalations. Supportrecruitmentandmonitoringstrategiestooptimizestudyperformance. Conductco-monitoringvisitstoensurequalityoversightandconsistencyacrossmonitoringactivities. Reviewandapprovemonitoringvisitreports,ensuringtimelyresolutionandescalationofidentifiedissues. Reviewmonitoringschedulesandsitevisitcalendarstoensurecompliancewithmonitoringplans. Monitorprotocoldeviations,datalistings,andqualitymetricstoproactivelyidentifyrisksandimplementmitigationstrategies. Leadstudyteammeetingsandprovideregularupdatesto Project Managersregardingsiteandcountryperformance. Ensureaccuratemaintenanceofstudydocumentationand Trial Master File(TMF)quality,whendelegated. Review CTMSdatatoensuretimelyandaccuraterecordingofcountry,site,andsubjectinformation. Supportinvestigatorpaymenttrackingandapprovalprocesseswhendelegated. Collaboratewith Project Managerson CRAonboarding,training,andhandoveractivities. Contributetostudycommunications,newsletters,andoperationalupdates. Provideprojectinsightsrelatedtoresourceutilization,revenuerecognition,andforecastingactivities. Participatein Investigator Meetingsandpresentmonitoringrequirementsandexpectationswhenrequired. Promoteproactiveissueresolutionandasolution-orientedapproachacrossstudyteams. Partnerwith CRALine Managersregardingstudyassignments,workloadplanning,andperformancediscussions.



Supportbusinessdevelopmentinitiatives,proposals,budgetdevelopment,andbiddefenseactivitiesasrequired. Qualifications Bachelor'sdegreein Life Sciences, Clinical Research, Nursing, Pharmacy,oranotherhealth-relatedfield. Minimumof5yearsofclinicalresearchexperience,includingsignificantexperienceasa Clinical Research Associate(CRA)withindependenton-sitemonitoringresponsibilities. Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study. Experiencecoordinatingoroverseeingclinicaltrialoperationsatastudy,country,orregionallevel. Strongunderstandingofclinicaltrialprocessesfromstart-upthroughcloseout. In-depthknowledgeof Good Clinical Practice(ICH-GCP),regulatoryrequirements,andclinicalresearchstandards. For candidates based in Italy 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. What We Offer Weprovideacompetitivecompensationpackage,comprehensivebenefits,andtheopportunityforpersonalandprofessionalgrowthinarewardingenvironment. You'llbejoiningateamthatvaluescollaboration,innovation,andmakingadifferenceinthelivesofpatients. At TFSHealth Science,you'llhavetheopportunitytoworkondiverseandimpactfulclinicaldevelopmentprogramswhilecollaboratingwithtalentedcolleaguesacrosstheglobe. ABit More About Us Ourjourneybeganover25yearsagoin Sweden,inthecityof Lund. Asaglobal CROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions. Wecurrentlyoperatein17countriesacross Europe, North America, Asia Pacific,andthe Middle East. Ourcorevaluesof Trust, Quality, Flexibility,and Passionarewhatmake TFSHealth Sciencethesuccessfulcompanyitistoday. Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.#Together We Make ADifference

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