AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.
Enablement drives the delivery of Business Process Excellence and Technology for the GMD Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.
The Enablement Specialist is a member of Enablement, and is responsible for the coordination/leading the activities ensuring lifecycle management and business continuity for Clinical Operations processes and tools, performing critical analysis to identify improvements, and developing reports and reporting tools for Clinical Operations systems. Coordinate/lead and deliver Enablement services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.
Individuals in this job may be assigned one or more roles relating to the development and maintenance of Enablement processes, systems and services owned by GMD Clinical Operations.
All Enablement Specialists will lead and project manage improvement projects as needed, and will contribute to functional and regional initiatives.
1) Operational Activities As the member of a specific activity team ES:
- Coordinates and delivers Enablement services across drug projects,
- Coordinates life cycle management and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials,
- Provides expert support to user communities including conducting relevant process/system/tool trainings, facilitating knowledge sharing, establishing of best practice, ensuring communication within Clinical Operations
- Conducts critical analyses of Clinical Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Define and develop User Requirement Specifications and User Acceptance Tests
- Maintains an awareness of the trends/changes in the external clinical process and technology environment to identify opportunities for improvement; participate in the evaluation and assessment of new technologies
- Contributes to and/or develops business cases for continuous improvement project
- Participates in change initiatives relating to Clinical Operations.
2) Customer Service and Support:
As the primary point of contact for Clinical Operations Enablement 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 Enablement 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) Other responsibilities possibly assigned (select below and attach description in
SPOC (Single Point Of Contact)
- University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines
- At least 2 year experience in Drug Development within a pharmaceutical or clinical background
- Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities
- Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality
- Computer proficiency
- Excellent knowledge of spoken and written English
- Strong business communication and presentation skills
- Ability to transfer knowledge efficiently (mentorship/trainings)
- Exhibit of AZ Values and Behaviours
- Expert reputation within AZ business area
- 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
- Some 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
- Some experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
We offer stable employment conditions, wide benefit package and the opportunity to participate in building a new team.