Local Study Associate Director

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