Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the Biopharmaceutical\xe2\x80\x99s R&D organisation, owning and providing industry leading technology and services on behalf of Clinical Operations and its internal and external Partnerships. Unify is our new internally built digital patient solution platform for patients, healthcare providers. Unify aims to make clinical trials easier and gives everyone involved more clarity, flexibility and peace of mind. Unify comprises of an app for patients (including eCOA and other Digital Health Technologies) and a web portal for healthcare professionals. It helps improve all participants clinical trial experience and outcomes by relieving many of the administrative burdens of the trial process and making the trials fit better into the patient\xe2\x80\x99s life. DPS stands for Digital Patient Solutions - DPS encompasses digital health technologies (DHTs) that a patient will engage with 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). DPS Business Analysts (BA) are the AstraZeneca (AZ) BA for a study, working together with the solution provider\xe2\x80\x99s team, leading AZ system design/requirement gathering activities ensuring they are in line with the study\xe2\x80\x99s digital strategy for digital technology services. Responsibilities:

• First contact point for novel solutions/technologies ensuring:
• Requirement elicitation and documentation
• Knowledge sharing and training with other Business Analyst
• Help defining the \xe2\x80\x9cmust-have\xe2\x80\x9d requirements before accepting new \xe2\x80\x9cat scale\xe2\x80\x9d solutions
• Contributing and maintaining vendor agnostic system requirements to ensure standardised solutions across all applicable platforms
• Driving efficiencies through standarisation in collaboration across all relevant stakeholders
• 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
  • conducting relevant process/system/tool trainings
  • facilitating knowledge sharing
  • establishment of best practices
  • ensuring communication within Clinical Operations
• Definition of system requirements in line with digital strategy
• Support UAT activities as consultant.
• 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
• Driving solution designs that are in line with best practice recommendations
• Identify high risk requirements and suggest possible testing scenarios for those to project team.
• Collaborating with the Test Lead 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:

• Emerging Technologies Director
• IT Business Partner
• Global Study Associate Director and/or Global Study Manager
• Study Implementation Lead
• eCOA & DPS Manager
• R&D Digital Health
• eCOA SME (Digital Health COA / Patient Centred Science)
• System Owner
• Supplier Representatives (Project Managers, Solution Designers) to agree on eCOA functionality, documents, trainings, testing and issue trouble shooting

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 5 year experience in requirements gathering and documentation, preferably within a regulated environment, such as a pharmaceutical or clinical area.
• Knowledge in Digital Health solutions
• Ability to work collaboratively in a cross functional setting with internal as well as external partners
• Ability to function well independently, and in complex groups and teams
• Experience in scaling up technical solutions through standarisation and process definition to ensure fast and standard delivery. Ability to identify and remove waste.
• Experience managing several stakeholders within a continuously evolving environment
• 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 with ALM tools such as Jira
• 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
• Ability to work within a continuously evolving environment
• 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
• Kaizen/Lean Six Sigma certification is an advantage