Clinical Research Manager

TFS HealthScience 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 Team as a Clinical Research Manager (CRM) - home based in Poland, Spain or Italy.

AtTFSHealthScience,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes.Wearelookingforanexperienced Clinical Research Manager (CRM) tojoinour Ophthalmology teamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries.

Thisisafull-time,home-basedopportunityopentocandidateslocatedin Poland, Spain, or Italy

About this role

Aspartofour Ophthalmology team,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals.

The Clinical Research Manager (CRM) willberesponsibleforcoordinatingandoverseeingcountryandsitemanagementactivitiesduringstudyconductincompliancewithcompanypolicies,SOPs,ICH-GCPguidelines,regulatoryrequirements,andcontractualobligations.

YouwillworkcloselywithProjectManagers,ClinicalResearchAssociates(CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,withinscope,andtothehighestqualitystandards.

Key Responsibilities

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Manageday-to-dayclinicaloperationsactivitiesforassignedprojectsinaccordancewithstudyprotocols,contracts,SOPs,ICH-GCPguidelines,andapplicableregulations.

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Serveastheprimarysponsorcontactforoperationalproject-specificissuesandstudydeliverables.

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Lead,coach,andsupportCRAs,ensuringproject-specifictrainingrequirementsarecompletedanddocumented.

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Overseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams.

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Developandimplementstudymonitoringplans,sitetrainingplans,andverificationinitiatives.

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Coordinateinvestigatormeetingsandsupportsiteandcountry-levelstudyreportingactivities.

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Ensurestudyprocessesandoperationalstrategiesremainpracticalandeffectivefromfeasibilitythroughstudycloseout.

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ActastheprimarypointofcontactforCRAsandmonitoringteams,providingguidanceonsite-relatedchallengesandescalations.

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Supportrecruitmentandmonitoringstrategiestooptimizestudyperformance.

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Conductco-monitoringvisitstoensurequalityoversightandconsistencyacrossmonitoringactivities.

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Reviewandapprovemonitoringvisitreports,ensuringtimelyresolutionandescalationofidentifiedissues.

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Reviewmonitoringschedulesandsitevisitcalendarstoensurecompliancewithmonitoringplans.

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Monitorprotocoldeviations,datalistings,andqualitymetricstoproactivelyidentifyrisksandimplementmitigationstrategies.

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LeadstudyteammeetingsandprovideregularupdatestoProjectManagersregardingsiteandcountryperformance.

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EnsureaccuratemaintenanceofstudydocumentationandTrialMasterFile(TMF)quality,whendelegated.

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ReviewCTMSdatatoensuretimelyandaccuraterecordingofcountry,site,andsubjectinformation.

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Supportinvestigatorpaymenttrackingandapprovalprocesseswhendelegated.

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CollaboratewithProjectManagersonCRAonboarding,training,andhandoveractivities.

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Contributetostudycommunications,newsletters,andoperationalupdates.

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Provideprojectinsightsrelatedtoresourceutilization,revenuerecognition,andforecastingactivities.

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ParticipateinInvestigatorMeetingsandpresentmonitoringrequirementsandexpectationswhenrequired.

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Promoteproactiveissueresolutionandasolution-orientedapproachacrossstudyteams.

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PartnerwithCRALineManagersregardingstudyassignments,workloadplanning,andperformancediscussions.

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Supportbusinessdevelopmentinitiatives,proposals,budgetdevelopment,andbiddefenseactivitiesasrequired.

Qualifications

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Bachelor'sdegreeinLifeSciences,ClinicalResearch,Nursing,Pharmacy,oranotherhealth-relatedfield.

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Minimumof5yearsofclinicalresearchexperience,includingsignificantexperienceasaClinicalResearchAssociate(CRA)withindependenton-sitemonitoringresponsibilities.

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Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study .

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Experiencecoordinatingoroverseeingclinicaltrialoperationsatastudy,country,orregionallevel.

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Strongunderstandingofclinicaltrialprocessesfromstart-upthroughcloseout.

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In-depthknowledgeofGoodClinicalPractice(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.

AtTFSHealthScience,you'llhavetheopportunitytoworkondiverseandimpactfulclinicaldevelopmentprogramswhilecollaboratingwithtalentedcolleaguesacrosstheglobe.

A Bit More About Us

Ourjourneybeganover25yearsagoinSweden,inthecityofLund.AsaglobalCROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions.Wecurrentlyoperatein17countriesacrossEurope,NorthAmerica,AsiaPacific,andtheMiddleEast.

Ourcorevaluesof Trust, Quality, Flexibility, and Passion arewhatmakeTFSHealthSciencethesuccessfulcompanyitistoday.Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.

#TogetherWeMakeADifference

Originally posted on Himalayas