Job title: Specialist, Global Clinical Solutions – 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 and Experience  

Essential  

• Bachelor’s degree (or equivalent education)  that supports skills and capabilities required for the role, enabling effective execution of responsibilities and appropriate interactions with internal and external customers. 

• Strong organizational and analytical skills  

• Ability to work collaboratively in a cross-functional environment. 

• Proven ability to multitask, manage time effectively and deliver to plan. 

• Previous administrative training/experience  

• Computer proficiency  

• Excellent spoken and written English  

• Strong communication skills  

• Demonstrated alignment with AZ Values and Behaviours  

Desirable  

• University degree in biological science, technology/computer science or a healthcare related field  

• Work experience in the pharmaceutical industry or in the environment of clinical study delivery/clinical development environments 

• Knowledge of pharmaceutical drug development, clinical study processes and associated industry regulations, ICH GCP; GxP trained  

• Demonstrated willingness and ability to train others on study support processes and procedures  

• Ability to proactively identify risks and issues as well as possible solutions  

• Some experience in validation/User Acceptance Testing of computerized systems in a regulated environment, preferably for the pharmaceutical industry. 

• Experience and/or knowledge of data and documents transfers infrastructures, processes and technologies (e.g. Globalscape, Snaplogic, sFTP, etc.) 

• Project management skills 

• Programming or data visualization experience/training (e.g. Power BI, Spotfire, Power Automate, VBA) 

• Experience with Patient data transfers, IFSD transfers, CRO documents transfer including accosiated processes , systems and technologies. 

• Knowledge of data privacy and data integrity regulations (e.g. GDPR).