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,orItaly
Aboutthisrole
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.
ABitMoreAboutUs
Ourjourneybeganover25yearsagoinSweden,inthecityofLund.AsaglobalCROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions.Wecurrentlyoperatein17countriesacrossEurope,NorthAmerica,AsiaPacific,andtheMiddleEast.
OurcorevaluesofTrust,Quality,Flexibility,andPassionarewhatmakeTFSHealthSciencethesuccessfulcompanyitistoday.Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.
#TogetherWeMakeADifference
TFS HealthScience is a leading global Contract Research Organization (CRO) with over 30 years of history, founded in Lund, Sweden. The company partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey, offering full service-capabilities, resourcing solutions, and Functional Service Provider (FSP) solutions. With over 600 professionals operating in more than 50 countries, TFS delivers tailored clinical research services across key therapeutic areas including Dermatology and Neurology, helping advance patient health through solution-driven clinical development approaches.
