• Support Global Study Leaders (GSL) and Global Study Associate Managers (GSAMs) by completing delegated study administrative work

• Initiate and lead the set-up, maintenance and closing of the electronic Trial Master File (eTMF) to ensure compliance to ICH GCP and AZ SOPs

• Interact/collaborate with Local Study Teams, other internal staff and external vendors in collection of regulatory and other essential documents

• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities.

• Proactively plan and collate the administrative appendices for the Clinical Study Report (CSR)

• Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements

• Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools

• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AZ compliance and regulatory authority needs

• Support the GSL tracking, reconciliation and follow-up of the study budget/payments in relevant systems (e.g. iBUY)

• Contribute to application, coordination, supply and tracking of study materials and equipment

• Contribute to collection of study supplies, if required, at the study close-out

• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs

• Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings; Liaise with internal and external participants and/or vendors; Prepares, contribute and distribute presentation material for meetings, newsletters and web-sites

• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Essential:

• Education preferably in medical or biological sciences or discipline associated with clinical research

• Basic knowledge of clinical research process and regulatory requirements

• Proven administrative skills, organizing and coordinating meeting/events

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。

• Strong computer proficiency in day-to-day tasks, especially in electronic file management, tracking tools, and preparation of presentation materials

• Fluent verbal and written communication in English

• Demonstrated ability to work with minimal supervision in a team environment

• Display effective organization and time management skills, attention to detail, and ability to multi-task in a high- volume environment with shifting priorities

• At least 1 year relevant clinical research experience in the pharmaceutical industry, academe or CRO

• Previous administrative training/experience

Desirable:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research

• Demonstrated ability to train others in study administration procedures

• Proven study-level administration/assistant or relevant experience

• Relevant clinical study experience