Unify Transition Business Analyst
hace 2 semanas
**Unify Transition Business Analyst (Associate Director, Global Clinical Solutions)**
**Location: hybrid work**
Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals 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 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 patients life.
The Unify Transition Business Analyst (BA) is a member of Global Clinical Solutions, Emerging Technology department and is responsible for the leadership, project management and capability build of Unify transition, ensuring that capabilities and resource within AZ is ready for expansion of this solution
The Unify Transition Business Analyst (BA) will work closely with Digital Health, System Owners, Alliance Management, Procurement and R&D IT (Information Technology). They will forge strong internal and external relationships ensuring UNIFY is able to meet customer needs for design and scaling. The BA will look to align system design/requirements gathering activities with those already used for other digital health technologies to enable UNIFY to meet business scaling requirements.
**Typical Accountabilities**:
- 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
- Definition of system requirements in line with digital strategy
- 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
- 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 continuous improvement
**Education, Qualifications, Skills and Experience**
**Essential**:
- Bachelor of Science (BSc) in an appropriate discipline or equivalent experience
- Extensive experience in Drug Development within a pharmaceutical or clinical background
- Strong business process, technology and Clinical Study information knowledge
- Strong operational knowledge of system processes in the clinical trial setting
- Demonstrated project management skills and proven skills to deliver to time, cost and quality
- Ability to work collaboratively, motivate and empower others to accomplish individual, team and organizational objectives
- Vendor Management - experience in working successfully and collaboratively with external partners delivering mutual benefit
- Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
**Desirable**:
- Extensive experience in Drug Development within a pharmaceutical company
- Comprehensive knowledge of ICH/GCP
- Experience of working in a global organisation with complex/geographical context
- Ability to set and manage priorities, resources, performance targets and project initiatives in a regional environment
- Experience of managing ambiguity whilst navigating through it
- Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
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