GCS Specialist - Business Analyst, eCOA (Fix term/ perm).
- Experience Level
- Experienced (non-manager)
The Global Clinical Solutions (GCS) Specialist (Business Analyst) is a member of the Study & Data Solutions team, and is responsible for the coordination/leading the system requirement activities ensuring Clinical Operations software lifecycle management and business continuity processes are followed, performing critical analysis to identify system requirements and improvements, and defining reports for analysis of Clinical Operations systems. This role plays a key role in delivering systems across projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.
The GCS Specialist (Business Analyst) is the AZ BA for a project working together with the vendors BA, leading AZ system design/requirement gathering activities ensuring they are in line with the project's Digital strategy for digital technology services such as eCOA (ePRO/eClinRO/eObsRO/ePerfO), patient engagement, telemedicine, data collection via connected devices and wearables.
Study & Data Solutions is part of 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 Clinical Operations and its internal and external Partnerships.
1) Operational Activities
As the GCS member of a specific activity team:
· Documentation of elicited user/functional requirements and traceability artifacts in alignment with AZ internal methodologies and external vendor needs across projects
· Writing testable user stories that capture our patient and investigator 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
o conducting relevant process/system/tool trainings
o facilitating knowledge sharing
o establishing of best practice
o ensuring communication within Clinical Operations
· Define and develop 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/vendors to drive efficiency and to ensure there is a common understanding and approach across our portfolio
2) Customer Service and Support:
As the primary point of contact for digital technology system requirements within a Study Team:
· 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 Study Teams 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.
3) Computer System Validation Oversight:
Provides guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.
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.
· University degree in related discipline, preferably in computer science or healthcare-related fields, or equivalent experience in the aforementioned disciplines
· At least 1 year experience in Requirements Gathering preferably within a regulated environment, such as pharmaceutical or clinical area
· Proven experience of working with complex integrated systems, using creative and strategic thinking to deliver exceptional results
· Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality
· Must have business acumen and comfort with technical teams, data, and systems
· Computer proficiency
· Excellent knowledge of spoken and written English
· Communication skills, knowledge sharing and problem-solving approach
· Any Project and Vendor management skills would be an advantage
In return, Clinical Operations GCS will offer a strong career development opportunity for the successful candidate. We are committed to develop the role of GCS Specialist and equip its incumbents with a strong training program and supporting network to help them progress to the next level.