Functional Process Owner EDC Platform (Associate Director, Global Clinical Solutions)

Location:Warsaw
Hybrid model of work(3 days from the office, 2 days from home)

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 EDC Platform 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 systemprocesses, 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 Development Operations system processes, Functional Process Owner is responsible for:

• The lifecycle management - design, development, implementation, maintenance, continuous improvement - of the system processes for the allocated area
• The development and delivery of high-quality guidelines, user manuals, training materials, relevant templates and toolkit documents
• Providing advice, training and end user support for the system processes and other system supporting documents
• Defining, tracking and monitoring key performance indicators of the allocated system process, and using these data to inform selection of system process improvements and input to cross-functional improvements.
• The delivery of Corrective and Preventive Actions (CAPA) to time and quality, and for acting on data or trends identified through the Quality & Risk Management process.
• Escalating risks and issues as required

The FPO will:

• Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the allocated system process area and provide feedback and clear rationale for any areas that will not be addressed
• Engage and influence internal and external key stakeholders to drive the system processes strategy, development and continuous improvement within the allocated area
• Liaise with relevant Process Owners, Business Process Management Office and Governance Team representatives to ensure alignment and cross-functional approach
• Liaise with relevant System Owner(s) to ensure that system processes and procedures are aligned
• Communicate and provide input to Business Process Management Office and Process Owners for evaluation of new SOPs and regulations related to the process.
• Be a member of Governance Teams relating to the allocated area
• Support audit and regulatory inspection planning, preparation and conduct.
• Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers.

2) Customer Service and Support:
As the primary point of contact for Development Operations GCS system processes within a Study Team:

• Understands the system 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 system process 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.

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

• 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.