(Associate) Country Study Manager - Cell Therapy

Job description

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 Skills Essential: 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 Solutions Internal: 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 06-7月-2026 Closing Date 30-12月-2026 AstraZeneca embraces diversity and equality of opportunity. 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. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. 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.