Clinical Research Manager
Pubblicato il 21-10-2026 - Trial Form Support in Montà
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 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. *****.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