Clinical Research Manager

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. AtTFSHealth

Science,youwillbepartofaglobalteamdedicatedtoadvancinginnovativetherapiesandimprovingpatientoutcomes.

Wearelookingforanexperienced Clinical Research Manager (CRM) tojoinour

Ophthalmologyteamandplayakeyroleinoverseeingclinicaltrialoperationsacrossmultiplestudiesandcountries.

Thisisafull-time,home-basedopportunityopentocandidateslocatedin

Poland,Spain,orItaly Aboutthisrole Aspartofour Ophthalmology team ,youwillworkalongsidepassionateandinnovativeprofessionalstoensureourcustomersachievetheirclinicaldevelopmentgoals.

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

Youwillworkcloselywith Project Managers ,Clinical Research Associates (CRAs),sponsors,andinvestigativesitestoensurestudiesaredeliveredontime,within scope,andtothehighestqualitystandards.

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

Serveastheprimarysponsorcontactforoperationalproject-specificissuesandstudydeliverables.

Lead,coach,andsupportCRAs,ensuring project-specifictrainingrequirementsarecompletedanddocumented.

Overseesitequalityandmonitoringdeliverablesthroughdirectsupervisionandguidanceofstudyteams.

Developandimplementstudymonitoringplans,sitetrainingplans,andverificationinitiatives.

Coordinateinvestigatormeetingsandsupportsiteandcountry-levelstudyreportingactivities.

Ensurestudyprocessesandoperationalstrategiesremainpracticalandeffectivefromfeasibilitythroughstudycloseout.

ActastheprimarypointofcontactforCRAsandmonitoringteams,providingguidanceonsite-relatedchallengesandescalations.

Supportrecruitmentandmonitoringstrategiestooptimizestudyperformance.

Conductco-monitoringvisitstoensurequalityoversightandconsistencyacrossmonitoringactivities.

Reviewandapprovemonitoringvisitreports,ensuringtimelyresolutionandescalationofidentifiedissues.

Reviewmonitoringschedulesandsitevisitcalendarstoensurecompliancewithmonitoringplans.

Monitorprotocoldeviations,data listings,andqualitymetricstoproactivelyidentifyrisksandimplementmitigationstrategies.

Leadstudyteammeetingsandprovideregularupdatesto Project Managersregardingsiteandcountryperformance .Ensureaccuratemaintenanceofstudydocumentationand Trial Master File (TMF) quality,when delegated.

ReviewCTMSdatatoensuretimelyandaccuraterecordingofcountry,site,andsubjectinformation.

Supportinvestigatorpaymenttrackingandapprovalprocesseswhendelegated.

Collaborate with Project Manager son CRAonboarding,training,andhandoveractivities.

Contributetostudycommunications,newsletters,andoperationalupdates.

Provideprojectinsightsrelatedtoresourceutilization,revenue recognition,andforecastingactivities.

Participate in Investigator Meetingsandpresentmonitoringrequirementsandexpectationswhenrequired .Promoteproactiveissueresolutionandasolution-orientedapproachacrossstudyteams.

PartnerwithCRALineManagersregardingstudyassignments,workload planning,andperformancediscussions.

Supportbusinessdevelopmentinitiatives,proposals,budget development,andbiddefenseactivitiesasrequired.

Qualifications Bachelor'sdegreein

Life Sciences,Clinical Research,Nursing,Pharmacy,oranotherhealth-related field.

Minimumof5yearsofclinicalresearchexperience,includingsignificantexperienceasa

Clinical Research Associate (CRA) withindependenton-sitemonitoringresponsibilities.

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

Experiencecoordinatingoroverseeingclinicaltrialoperationsatastudy,country,orregionallevel.

Strongunderstandingofclinicaltrialprocessesfr(ICH-GCP),regulatory requirements,andclinicalresearchstandards.

For candidates based in Italy…