Specialist, Global Clinical Solutions – STER

Job title: Specialist, GlobalClinicalSolutions – STER 

Location: Warsaw, Poland
Work model: Hybrid (3 days per week in office)

Global Clinical Solutions department (GCS) drives the delivery of Business Process Excellence and Technology for the Clinical Operations organization, owning and providing industry leading processes, technology and services on behalf of Clinical Operations and it’s internal and external Partnerships.   

As a Specialist, GCS you will deliver global centralized services, set up and maintain systems and data, ensure compliance and quality to enable on-time, cost-effective clinical program delivery across internal and external stakeholders including all delivery models.  

Service for Transfer of Essential Records (STER)Specialist ensures smooth, efficient, secure, GxP compliant transfers of essential records (patient data, CRO eTMF, imported final subject data) to and from AstraZeneca. You will collaborate closely with vendors, IT funcions, and serve Study Teams and patients by protecting data integrity and data privacy. 

Education,Qualifications, Skills andExperience

Essential

• Bachelor’sdegree(orequivalenteducation) thatsupportsskillsandcapabilitiesrequiredfor the role,enablingeffectiveexecutionofresponsibilitiesandappropriateinteractionswithinternalandexternalcustomers.

• Strongorganizationalandanalyticalskills

• Abilitytoworkcollaborativelyin a cross-functionalenvironment.

• Provenabilitytomultitask,managetimeeffectivelyanddeliverto plan.

• Previousadministrativetraining/experience

• Computerproficiency

• ExcellentspokenandwrittenEnglish 

• Strongcommunicationskills

• Demonstratedalignmentwith AZValuesandBehaviours

Desirable

• Universitydegreeinbiologicalscience,technology/computerscienceorahealthcarerelatedfield 

• Workexperiencein the pharmaceuticalindustryorin the environment ofclinicalstudydelivery/clinicaldevelopmentenvironments

• Knowledge of pharmaceuticaldrugdevelopment,clinicalstudyprocessesandassociatedindustryregulations, ICH GCP;GxPtrained

• Demonstratedwillingnessandabilitytotrainothersonstudysupportprocessesandprocedures

• Abilitytoproactivelyidentifyrisksandissuesaswellas possiblesolutions

• Someexperienceinvalidation/UserAcceptanceTestingofcomputerizedsystemsin aregulatedenvironment,preferablyfor thepharmaceuticalindustry.

• Experienceand/orknowledgeofdataanddocumentstransfersinfrastructures,processesandtechnologies(e.g.Globalscape,Snaplogic,sFTP, etc.)

• Project managementskills

• Programmingordatavisualizationexperience/training(e.g. Power BI,Spotfire, PowerAutomate, VBA)

• ExperiencewithPatientdatatransfers,IFSDtransfers,CROdocumentstransferincludingaccosiatedprocesses,systemsandtechnologies.

• Knowledgeofdataprivacyand dataintegrityregulations(e.g. GDPR).