Job Description

Global Clinical Solutions Manager \xe2\x80\x93 Business Analysist, DPS/eCOA Location: Warsaw, hybrid work
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 \xe2\x80\x93 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\xe2\x80\x99s BA, leading AZ system design/requirement gathering activities ensuring they are in line with the study\xe2\x80\x99s 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\xe2\x80\x99 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

o conducting relevant process/system/tool trainings o facilitating knowledge sharing o establishment of best practices o 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\xe2\x80\x99s 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.

Candidate profile:

• University degree in related discipline, 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 \xe2\x80\x93 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 understanding 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