21 ott - Roma
Trial Form Support
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.
Per il seguente ruolo potrebbero essere richieste diverse soft skill ed esperienze. La preghiamo di consultare attentamente la panoramica riportata di seguito.
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 – 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.WhatWeOfferWeprovideacompetitivecompensationpackage,comprehensivebenefits,andtheopportunityforpersonalandprofessionalgrowthinarewardingenvironment.
You'llbejoiningateamthatvaluescollaboration,innovation,andmakingadifferenceinthelivesofpatients.
AtTFSHealthScience,you'llhavetheopportunitytoworkondiverseandimpactfulclinicaldevelopmentprogramswhilecollaboratingwithtalentedcolleaguesacrosstheglobe. ABitMoreAboutUsOurjourneybeganover25yearsagoinSweden,inthecityofLund.
AsaglobalCROwiththeultimategoalofensuringpatients'safetyandwell-being,weprovidebiotechnologyandpharmaceuticalcompanieswithtailoredclinicaldevelopmentsolutions.
Wecurrentlyoperatein17countriesacrossEurope,NorthAmerica,AsiaPacific,andtheMiddleEast.
OurcorevaluesofTrust,Quality,Flexibility,andPassionarewhatmakeTFSHealthSciencethesuccessfulcompanyitistoday. xkiyazw
Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.#TogetherWeMakeADifference
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