Clinical Research Manager

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 Originally posted on Himalayas