Testing Engineer - UAT Lead 2
Typical Accountabilities:
• Plans and leads the delivery of all components of a clinical development project
• Leader of a clinical development team, key player during the whole process, and responsible for consistency during the course of the project
• Develops recruitment strategies, and the delivery of the approved Clinical Development Protocol
• Works with Line Managers to identify resource need and secure resources from various departments to ensure flexible and timely formation of the Clinical Study Teams and progression of deliverables
• Forecasts and day-to-day management of timelines, budget, materials and development of detailed project plans and feasibility assessment
• Leads and implements globally agreed Clinical Development strategies including process and technology
• Plans and leads activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required
• Develops & manages contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
• Leads preparation and delivery of clinical development deliverables
• Establishes and maintains key interactions with stakeholders
• Plans, leads and ensures appropriate training is achieved at Investigator/monitor meetings
• Coordinates and/or contribute to timely delivery of SD components of submissions to regulatory authorities (e.g. CSRs, CTDs, INDs, IND annual reports)
• Leads and optimizes the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate skill centre managers
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) -
What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time
Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s degree in biological science or healthcare-related field; Experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Demonstrated leadership ability in a team environment; Experience in project management methodologies; Advanced knowledge of the clinical study and drug development processes, GCP/ICH guidelines; Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills; Budgetary and resource management planning experience; Willingness to travel both domestically and internationally; Excellent knowledge of spoken and written English; Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Desirable: Effectively plans, coordinates and facilitates delivery of team objectives; Demonstrates appropriate Project Management skills; Demonstrates operational expertise in risk management and contingency planning; Has an appropriate understanding of disease state and familiarity with the latest research and thought leaders; Demonstrates an extensive knowledge of the clinical study and drug development process, GCP/ICH guidelines and SOPs; Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and SD systems/software in an e-enabled environment; Demonstrates conceptual, analytical and strategic thinking; Effective problem and conflict resolution skills and proven team focus; Demonstrates good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information AstraZeneca Job Description – Study Delivery Leader
Key Relationship to reach solutions:
• Internal (to AZ or team): Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate
• External (to AZ): External service providers; Marketing Company personnel
• Plans and leads the delivery of all components of a clinical development project
• Leader of a clinical development team, key player during the whole process, and responsible for consistency during the course of the project
• Develops recruitment strategies, and the delivery of the approved Clinical Development Protocol
• Works with Line Managers to identify resource need and secure resources from various departments to ensure flexible and timely formation of the Clinical Study Teams and progression of deliverables
• Forecasts and day-to-day management of timelines, budget, materials and development of detailed project plans and feasibility assessment
• Leads and implements globally agreed Clinical Development strategies including process and technology
• Plans and leads activities associated with audits in liaison with CQA; contribute to regulatory inspection strategy teams as required
• Develops & manages contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
• Leads preparation and delivery of clinical development deliverables
• Establishes and maintains key interactions with stakeholders
• Plans, leads and ensures appropriate training is achieved at Investigator/monitor meetings
• Coordinates and/or contribute to timely delivery of SD components of submissions to regulatory authorities (e.g. CSRs, CTDs, INDs, IND annual reports)
• Leads and optimizes the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate skill centre managers
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) -
What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time
Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s degree in biological science or healthcare-related field; Experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Demonstrated leadership ability in a team environment; Experience in project management methodologies; Advanced knowledge of the clinical study and drug development processes, GCP/ICH guidelines; Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills; Budgetary and resource management planning experience; Willingness to travel both domestically and internationally; Excellent knowledge of spoken and written English; Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Desirable: Effectively plans, coordinates and facilitates delivery of team objectives; Demonstrates appropriate Project Management skills; Demonstrates operational expertise in risk management and contingency planning; Has an appropriate understanding of disease state and familiarity with the latest research and thought leaders; Demonstrates an extensive knowledge of the clinical study and drug development process, GCP/ICH guidelines and SOPs; Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of AZ and SD systems/software in an e-enabled environment; Demonstrates conceptual, analytical and strategic thinking; Effective problem and conflict resolution skills and proven team focus; Demonstrates good team skills including cooperation, concern for impact, willingness to learn from others, and sharing of relevant information AstraZeneca Job Description – Study Delivery Leader
Key Relationship to reach solutions:
• Internal (to AZ or team): Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate
• External (to AZ): External service providers; Marketing Company personnel
Date Posted
07-May-2025Closing Date
24-Jun-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. ]]>We’ll keep you up to date
