AstraZeneca
FunctionalProcessOwnerEDCPlatform
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Functional Process Owner EDC Platform at AstraZeneca. Skills: process management, continuous improvement, stakeholder management, Drug Development. Lead system process lifecycle management. Develop guidelines and user manuals”
What You'll Achieve.
Ensure customer needs are met; Enable optimal end-to-end delivery of clinical studies; Achieve continuous improvement and value creation; Ensure system processes meet AZ requirements; Drive performance; Bring new solutions to customers; Ensure effective resolution of system process risks and issues
Industry & Context.
problem solving
What They're Looking For.
Must Have
Bachelor of Science (BSc) in an appropriate discipline or equivalent experience, Extensive experience in Drug Development within a pharmaceutical or clinical background, business process, technology and Clinical Study information knowledge, 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.
Nice to Have
Expert reputation within the business and industry, Experience of utilizing standard process improvement methodologies (e.g. , Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement, Experience in the development and management of Business Processes to deliver business performance, Comprehensive knowledge of ICH/GCP, Extensive experience in Validation of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX, etc. ) requirements for computerised systems and infrastructure, Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment., Experience of planning, implementing EMR2EDC Middleware systems for clinical trials, including Project Management of activities related to clinical study teams and/or investigational sites, Experience in Medidata Rave including iMedidata user and site administration, report administration, core configuration, study build and edit check programming.
What You'll Do.
Lead system process lifecycle management
Develop guidelines and user manuals
Provide advice and end user support
Define and monitor key performance indicators
Deliver Corrective and Preventive Actions (CAPA)
Understand and address customer requirements
Engage stakeholders for process strategy
Liaise with Process Owners and Governance
Support audit and inspection planning
Promote innovative ideas for performance
Understand system processes and needs
Resolve system process risks and issues
Share lessons learned and best practices
How You'll Work.
Team & Collaboration
Work closely with System Owner, vendor(s); Collaborate with Business Process Management Office (BPMO); Engage with R&D IT; Partner with internal and external customers and stakeholders; Collaborate closely with BPM Lead; Liaise with relevant Process Owners; Liaise with Business Process Management Office; Liaise with Governance Team representatives; Liaise with relevant System Owner(s); Communicate and provide input to Business Process Management Office; Act as a member of Governance Teams; Work collaboratively with external partners; Work collaboratively with internal teams; Engage and influence internal and external key stakeholders
Communication Scope
Demonstrated excellent written and verbal communication; influencing skills; negotiation; collaboration; problem solving; presentation; knowledge transfer (mentoring); conflict management; interpersonal skills
Process & Methodology
Demonstrated project management skills, Proven skills to deliver to time, cost and quality, Lead and manage improvement projects, Project Management of activities
Full Job Description
**Location:** Warsaw, Poland **Hybrid model of work:** 3 days in office, 2 remote per week 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 Development Operations and its internal and external Partnerships. The Functional Process Owner (FPO) for the EMR2EDC tools is a member of the Global Clinical Solutions, GCS Technologies department and is end-to-end responsible for the leadership, lifecycle management and continuous improvement of assigned system processes, guidelines and user manuals. The FPO works closely with System Owner, vendor(s) if applicable, Business Process Management Office (BPMO), R&D IT (Information Technology), internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. Responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery, utilising tools and techniques to achieve continuous improvement and value creation (i.e., Lean Six Sigma). The FPO ensures that the defined system processes, guidelines and user manuals meets AZ requirements, standards, best practices and they are in line with SOPs and other processes. The FPO collaborates closely with BPM Lead to confirm alignment of managed processes with overarching higher-level processes (e.g. SOPs). The FPO represents the business interests in strategy discussions and provides strategic advice to the Governance team in securing long-term business success in their assigned areas. Reviews and approves (if acceptable) identified system process risks and mitigations. All Functional Process Owners will lead and manage improvement projects as needed, and will contribute to functional and regional initiatives. **Typical Accountabilities** 1) System Process Ownership: As the allocated owner for a specific set of
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