Urgent! Business Analyst, DPS/eCOA in Global Clinical Solutions (18 months Fix-term/secondment). Job Opening In Warsaw – Now Hiring AstraZeneca
Job title: Business Analyst, DPS/eCOA in Global Clinical Solutions
Type of contract: 18 months Fix-term/secondment
Location: Warsaw, Poland
Hybrid Model: 3 days per week from office
Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca (AZ) for its internal and external stakeholders.
eCOA stands for electronic Clinical Outcome Assessment (including ePRO – electronic Patient Reported Outcome) and by definition directly or indirectly measures how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit.
It measures may provide important patient perspective on the disease and the treatment received; an evaluation that provides clinically important information that is not captured by conventional anti-tumor efficacy data and adverse event reporting.
DPS stands for Digital Patient Solutions - DPS encompass the entire digital experience of a patient in a specific research setting or study (can include but not limited to eCOA with integrated sensors, devices and/or wearables, patient engagement, telemedicine, eConsent, geo-fencing).
The eCOA and DPS Business Analyst is the AstraZeneca (AZ) BA for a study, working together with the service provider’s BA, leading AZ system design/requirement gathering activities ensuring they are in line with the study’s digital strategy for digital technology services such as eCOA, patient engagement, telemedicine, data collection via connected devices and wearables.
Study & Data Solutions is part of the Global Clinical Solutions team that drives the delivery of Business Process Excellence and Technology for the Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Develpment Operations and its internal and external Partners.
Responsibilities:
Documentation of elicited user/functional requirements and traceability artifacts in alignment with AZ internal methodologies and external supplier needs across projects
Writing testable user stories that capture our patient, investigator and study needs’ within systems
Coordinates software lifecycle management and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials,
Provides expert support to user communities including
conducting relevant process/system/tool trainings
facilitating knowledge sharing
establishment of best practices
ensuring communication within Clinical Operations
Define and develop User Requirement Specifications, review Supplier User Requirement Specifications to ensure it was implemented as per AZ User Requirement Specifications and consult to ensure User Acceptance Tests cover all system requirements.
Standardising how we define requirements for particular system functionality across different projects/suppliers to drive efficiency and to ensure there is a common understanding and approach across our portfolio
Understands the processes, technology and services the study team relies on, their needs and pain points.
Uses this knowledge to provide advice and guidance, removes barriers, provides solutions and identifies opportunities for improvement
Ensures the effective resolution of process, technology and service risks and issues that impede the system’s progress and effective delivery.
Identifies and engages with the right process, technology and service experts, and expertly utilises escalation routes and governance bodies to gain traction and deliver rapid solutions
Shares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.
Identify high risk requirements and suggest possible testing scenarios for those to eCOA & DPS Manager.
Collaborating with the eCOA & DPS Manager to define the testing approach and the components of testing to ensure traceability of requirements and effectiveness of overall solution.
Internal and External Contacts - Some examples of contacts/partners are:
Global Study Associate Director and/or Global Study Manager
Solution Implemetion Lead
eCOA & DPS Manager/Specialist
COA SME
Supplier Representatives (Project Managers, Solution Designers) to agree on eCOA functionality, documents, trainings, testing and issue trouble shooting
UAT Team (GCS)
System Owner; Process Owner
Business Quality Manager
Alliance Management
Candidate profile:
University degree, preferably in computer science, biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines
At least 2 year experience in requirements gathering and documentation, preferably within a regulated environment, such as pharmaceutical or clinical area.
Experience in Validation/User Acceptance Testing of computerized systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts (including test scripts execution), Functional Risk Assessment etc.
Proven experience of working with complex integrated systems, using creative and strategic thinking to deliver exceptional results
Experience in software development within a pharmaceutical or clinical space is an advantage
Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities is an advantage.
Knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure – understanding of technical documentation is an advantage
Skills and capabilities:
Ability to work collaboratively
Proven organizational and analytical skills
Proven skills to deliver to time, cost and quality
Proven understandning of the Software Development Life Cycle (SDLC)
Computer proficiency
Personal Development focused Strong business communication and presentation skills
Knowledge sharing and problem-solving approach
Continuous improvement attitude
Project and Supplier management skills would be an advantage
Date Posted
14-paź-2025Closing Date
23-paź-2025✨ Smart • Intelligent • Private • Secure
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Great news! AstraZeneca is currently hiring and seeking a Business Analyst, DPS/eCOA in Global Clinical Solutions (18 months Fix term/secondment). to join their team. Feel free to download the job details.
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