jobexpo.web.id – Enablement Manager, Rave Global Maintenance Team
Cambridge / Gothenburg / Warsaw / Gaithersburg
Process and Enabling Solutions (PES) drives the delivery of Business Process Excellence and Technology for the BioPharmaceuticals R&D organisation, owning and providing industry leading process, technology and services on behalf of Development Operations and its internal and external Partnerships.
The Enablement Manager is a member of PES, and is responsible for the leadership, lifecycle management and continuous improvement of a specific Development Operations process, system or service. Working collaboratively with internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. The Enablement Manager is 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 such as Lean Six Sigma.
Individuals in this job are assigned one or more roles relating to the development and maintenance of PES processes, systems and services owned by BioPharmaceuticals R&D Development Operations.
All Enablement Managers will lead and project manage improvement projects as needed, and will contribute to functional and regional initiatives.
1) Process, System or Service Ownership:
As the allocated owner for a specific Development Operations process, system or service EM is:
- Responsible for the design, development, implementation, maintenance, continuous improvement and ongoing customer support for the allocated area
- Responsible for lifecycle management of all procedural or system documents within the allocated area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
- Responsible for the effective and timely communication of information, and for the development and delivery of high quality training materials for the allocated area
- Responsible for providing training, advice and end user support for the allocated process, system or service
- Responsible for the leadership of service delivery teams within the allocated area
- Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement within the allocated area
- Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the allocated area. Work with PES Leadership and Clinical Development Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed
- Member of Executive Steering Committees and Governance Teams relating to the allocated area
- Responsible for monitoring performance of the allocated process, system or service. Define, track and monitor key performance indicators and use these data to inform selection of process improvements and input to cross-functional improvements, working in collaboration with PES Leadership
- Support audit and regulatory inspection planning, preparation and conduct. Responsible for the delivery of Corrective and Preventive Actions to time and quality, and for acting on data or trends identified through the Quality & Risk Management process. Escalate risks and issues to Enablement Leadership as required
- 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 PES processes, technology and services 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 PES 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.
4) Local Line Management:
- Provides local management and leadership to fulfill management accountabilities and local employment law requirements
- Attracts, develop and retain top talent and actively work to promote team building and morale within the department
- Provides direction, real time situational mentoring, career development guidance, and coaching as appropriate
- Provides performance management, performance assessment and reward and recognition proposals for direct reports.
Education, Qualifications, Skills and Experience
- Bachelor’s of Science in an appropriate discipline or equivalent experience
- Extensive experience in Drug Development within a pharmaceutical or clinical background
- High level of business process, technology and Clinical Study information knowledge
- Experience of configuration of Rave User and Site Administration modules including site set up and assignment of roles, permissions and eLearning requirements
- Knowledge and understanding of Rave URL level settings including knowledge of Rave Core Configuration Workflow, Lab administration module, Report management module, PDF profile settings
- 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
- 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.
Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to data management, operations teams and other stakeholders Experience of working with Rave EDC (Rave X) and other Medidata products would be ideal but not necessary * 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 Process 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
Applications Open 10th February 2020
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