Functional Process Owner

Join Natek as a Functional Process Owner and support a global and well-known pharmaceutical company.

The Functional Process Owner (FPO) for Redefine Clinical Data Flow (RCDF) Projects is a member of the Global Clinical Solutions, Technology 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). 

On this role, you will be responsible for:

• Ensuring 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
• The lifecycle management - design, development, implementation, maintenance, continuous improvement - of the system processes for the allocated area
• Engage and influence internal and external key stakeholders to drive the system processes strategy, development and continuous improvement within 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

Our requirements

• At least 5+ years of experience in a similar role
• 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.

Nice to have:

• 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 Technical Writing
• Experience in the development and management of Business Processes to deliver business performance
• Comprehensive knowledge of ICH/GCP
• 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
• Experience in Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.