Junior Real World Evidence Specialist

Brief Job Description

Member of the Country Medical Affairs Team supporting scientific evidence and data generation activities across therapeutic areas. This is an operational and supportive role, focused on executing tasks within RWE projects under the supervision of experienced specialists. Responsible for administrative support, operational coordination, ongoing monitoring of research project progress, as well as contributing to the development of research protocols and scientific publications under senior guidance. 

Job Responsibilities:

• Assist in conducting evidence gap analyses 

• Support the definition of study objectives, endpoints, inclusion/exclusion criteria, and data collection methods 

• Support day-to-day coordination of real-world data generation projects, including: 

• Vendor contracting processes 

• Maintaining detailed budget tracking spreadsheets for all assigned projects  

• Participation in feasibility processes (remote or on-site) 

• Preparation of ethics applications for submission 

• Site contracting processes 

• Start-up activities including site initiation visits preparation, site training materials, and internal user onboarding 

• Maintaining and organizing the Trial Master File (TMF) 

• Study documents preparation 

• Identifying operational risks and maintaining study risk registers 

• Design of Case Report Forms (CRFs) aligned with protocol requirements, ensuring data capture is consistent with study objectives 

• Set-up and maintenance of study systems 

• Study registration in public registries (e.g., ClinicalTrials.gov, EU PAS Register) and ensure timely updates 

• Tracking study progress including milestones, patient recruitment, and trial documentation 

• CRF data review, query processing, discrepancy management, and ad hoc report generation 

• Maintaining day-to-day operational communication with CROs, and other vendors 

• Organizing study project meetings, steering committee meetings, and investigator meetings 

• Assist in the preparation of scientific manuscripts, abstracts, and posters for peer-reviewed journals and congresses 

• Conduct systematic and targeted literature reviews 

Typical Accountabilities (per AZ framework and regulatory expectations):

• Support the Evidence Generation process for MC Poland under supervisor guidance 

• Participate in the preparation and delivery of AZ-generated evidence projects 

• Contribute to the timely delivery of research protocols and scientific publications in accordance with project timelines 

• Ensure all scientific outputs adhere to Good Publication Practice (GPP) guidelines, ICMJE recommendations, and AZ internal standards 

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role 

• Report potential issues of non-compliance 

• Support monitoring of milestones, reporting requirements, and budget spend 

Requirements:

Essential

• MD or Biology/Pharmacy/science-related Master’s degree 

• Experience in conducting RWE projects  

• Basic knowledge of market access, economic understanding, as well as knowledge of the motivations of involved stakeholders 

• Good project management skills  

• Understanding and ability to interpret clinical data 

• Good presentation and communication skills 

• Ability to work as part of a team with colleagues from other areas 

• Ideally experience in health economics and outcome research from the pharmaceutical industry 

• Ability to conceptualize and communicate content well 

• Analytical mindset, open, flexible and team-oriented personality 

• Very good English skills 

• Understanding of ICH-GCP principles and regulatory framework for observational studies 

• Effective time management skills  

• Good knowledge of MS Office (Word, Excel, PowerPoint)  

Desirable:

• MD, Master’s degree or PhD in epidemiology, health research methodology, biostatistics and/or data analytics. 

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.