Typical Accountabilities- Coordinate lifecycle management, enhancement, and business continuity for Study Delivery processes, systems, reporting, and technology across the clinical research portfolio.- Develop, implement, and continuously improves reporting tools, metrics, and analytical processes, identifying new opportunities for optimization and efficiency.- Lead the delivery of centrally managed study services—such as document management, clinical trial transparency, and system training—to ensure consistency, compliance, and best practice across all drug projects.- Serve as the principal contact for document management activities from initial production/import through completion of the Clinical Study Report and regulatory archiving.- Collaborate with internal stakeholders (Study Delivery, Clinical Development, Data Management, Patient Safety, Compliance) and external partners (service providers, regulatory bodies) to ensure seamless study administration and regulatory compliance.- Facilitate dynamic communication channels to share knowledge, disseminate best practices, and provide guidance and training on current and evolving study systems, standards, and procedures.- Act as a subject matter expert for risk management, contingency planning, and change management, proactively identifying and resolving operational issues or process non-compliance.- Maintain up-to-date awareness of external trends, regulatory requirements, and enabling technologies in clinical trial management to drive the adoption of fit-for-purpose solutions and business process improvements.- Manage and track study materials, equipment, and controlled documents to ensure high standards of quality and audit readiness.- Oversee administrative tasks (including audit and inspection support), ensuring robust documentation practices and regulatory compliance throughout all phases of study execution.- Advise and support project teams in developing and implementing effective study methodologies, harmonized processes, and regulatory best practices.Qualifications and SkillsEssential: Bachelors of Science degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavors; Significant experience in the pharmaceutical industry working in an environment of clinical study delivery/clinical development processes; Demonstrated aptitude for process and technology; Experience with process and training design and implementation; Demonstrated leadership ability in a team environment; proven ability to facilitate team building and teamwork; Proven leadership experiences (people and project) including team facilitation skills and strong collaborative communications ability to diverse client base; Excellent written and verbal communication skills in English; Proven excellent negotiation, collaboration, interpersonal, problem solving and conflict resolution skills; Proven Project Management skills; Experience working internationally; Ability to travel both domestic and international; Customer focused; Performance driven.Desirable: Advanced degree in biological sciences, healthcare related field or business; Clinical study delivery operational experience; Experience in cross-functional pharmaceutical development; In depth understanding of Business Continuity Planning.; Ability to effectively lead complex non-drug projects in a world-wide environment through in depth understanding of AZ PMF, IPOM and DMAIC Change Management processes; Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment; Proven Conceptual, Analytical and Strategic thinking; concern for standards and willingness to learn from others; Proven Project management skills; Demonstrates operational expertise in risk management and contingency planning; Has in depth knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes; Positive change management skills, individually, team and business seeing change as an opportunity to improve performance and add value to the business; Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.Key Relationship to Reach SolutionsInternal: Study Delivery personnel; Study delivery team personnel; Clinical Development personnel; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate.External: External service providers; Marketing Company personnel.Date Posted
28-Oct-2026Closing Date
31-Jan-2027AstraZeneca embraces diversity and equality of opportunity. Â We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. Â We believe that the more inclusive we are, the better our work will be. Â We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. Â We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
