TFSHealth Science 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.
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 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. *****.
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 (Lazio)
🏢 Trial Form Support
📍 Lazio