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.

Aboutthisrole

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

ABitMoreAboutUs

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