Clinical Research Manager

Trial Form Support; Roma; Remote; EUR 63,000 - 65,000; Full time

Benefits offered by this job

Lunch vouchers

Health insurance

Pension

Car allowance where applicable

Job summary

TFSHealthScience is seeking an experienced Clinical Research Manager (CRM) to join our Ophthalmology team. This home-based role is open to candidates located in Poland, Spain, or Italy, including Italy’s Lazio/Roma area.

You will coordinate country- and site-management activities, ensure compliance with ICH‑GCP and regulatory requirements, and drive on-time, high-quality study delivery. You will lead and coach CRAs, supervise monitoring activities, and support sponsor communications, with

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 5 years of clinical research experience including significant on-site monitoring responsibilities.
• Minimum 1 year as Unmasked CRA/CRM in Ophthalmology studies.

Responsibilities

• Coordinate country- and site-management activities per study protocols, SOPs and ICH-GCP.
• Serve as primary sponsor contact for operational issues and study deliverables.
• Lead CRAs, oversee training and ensure documentation of training.
• Oversee site quality and monitoring deliverables under direct supervision.
• Develop and implement monitoring and site training plans.

Skills

On-site monitoring

CRA experience

Clinical trial coordination

ICH-GCP knowledge

Sponsor communications

Project management

Education

Bachelor's degree in Life Sciences/Clinical Research/ Nursing/ Pharmacy/ health-related field

Tools

CTMS

TMF management

Job description

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,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.

Thesevaluesshapeourculture,reflectwhatwestandfor,andguidehowweworkeveryday.#TogetherWeMakeADifference