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AstraZeneca

Global pharmaceutical company developing prescription medicines

Local Study Associate Director

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeTaiwanNo salary listed

About the Job

Requirements

  • A Bachelor of Science degree in a related discipline, preferably medical or biological science, or equivalent work experience in directly related fields.
  • Significant pharmaceutical-industry experience working in clinical study delivery or clinical development processes.
  • Aptitude for process and technology.
  • Experience with process and training design and implementation.
  • Leadership ability in a team environment, including team facilitation and teamwork.
  • Experience in people and project leadership, team facilitation, and collaborative communication with diverse clients.
  • Excellent written and verbal communication skills in English.
  • Negotiation, collaboration, interpersonal, problem-solving, and conflict-resolution skills.
  • Project management skills.
  • Experience working internationally.
  • Ability to travel domestically and internationally.

Responsibilities

  • Coordinate lifecycle management, enhancement, and business continuity for Study Delivery processes, systems, reporting, and technology across the clinical research portfolio.
  • Develop, implement, and continuously improve reporting tools, metrics, and analytical processes, identifying opportunities for optimization and efficiency.
  • Lead centrally managed study services, including document management, clinical trial transparency, and system training, ensuring consistency, compliance, and best practices across drug projects.
  • Serve as the principal contact for document management from initial production or import through completion of the Clinical Study Report and regulatory archiving.
  • Collaborate with internal stakeholders across Study Delivery, Clinical Development, Data Management, Patient Safety, and Compliance, and with external service providers and regulatory bodies to support study administration and regulatory compliance.
  • Facilitate communication channels to share knowledge, disseminate best practices, and provide guidance and training on study systems, standards, and procedures.
  • Act as a subject matter expert for risk management, contingency planning, and change management, identifying and resolving operational issues or process non-compliance.
  • Maintain awareness of external trends, regulatory requirements, and enabling technologies in clinical trial management to drive fit-for-purpose solutions and business-process improvements.
  • Manage and track study materials, equipment, and controlled documents to maintain quality and audit readiness.
  • Oversee administrative tasks, including audit and inspection support, ensuring documentation practices and regulatory compliance throughout study execution.
  • Advise and support project teams in developing and implementing study methodologies, harmonized processes, and regulatory best practices.

Desired Qualifications

  • An advanced degree in biological sciences, a 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 lead complex non-drug projects in a worldwide environment through understanding of AZ PMF, IPOM, and DMAIC Change Management processes.
  • Ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment.
  • Conceptual, analytical, and strategic thinking.
  • Concern for standards and willingness to learn from others.
  • Project management skills.
  • Operational expertise in risk management and contingency planning.
  • In-depth knowledge of GCP and AZ procedural documents as they relate to Study Delivery systems and processes.
  • Positive change-management skills, including seeing change as an opportunity to improve performance and add business value.
  • Professionalism, diplomacy, mutual respect, ability to manage and value diversity and cultural differences, and ability to promote productivity through encouragement.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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