- Assist CRAs to prepare, distribute, maintain and archive investigator site files in accordance with the standard operating procedures and the ICH-GCP guidelines
- Support TMF management at study and site level and optimize TMF management process
- Manage all payments related to clinical trial activities. .
- Draft and prepare investigator site budgets and agreements as well as EC and RA submission documents under the guidance of CRA and CSM
- Responsible for study drug management, including import license applications, custom clearance and fulfil regulatory requirements (i.e. PLAMMS); lead cross function team to response customs issues; responsible for customs policies interpretation to SDT, Supply Chain, LST
- Support procurement processes, including but not limited to, vendor bidding, assessments, due diligence, setup PO/PR for CROs and other vendors, purchasing clinical supply and equipment, in collaboration with CSM and the Procurement team
- Coach and train junior/newly joined colleague together with line manager.
- Work with line manager for team working process development, simplify and digitalization according to business needs, develop the digital tool (including Power App or MS forms etc.) to optimize the working process.
- Administrative and logistics support for the internal team, including but not limited to, meetings arrangement, supply and document shipping, etc
- Bachelor degree or above in life science or healthcare-related field, or equivalent.
- At least 5-year experience as CTA/CTC/CRC or equivalent experience.
- Knowledge in clinical study process and understanding of the ICH/GCP guideline.
- Good interpersonal skills and ability to work in an international team environment.
- Good computer skills in Microsoft and other software.
- Proficient written and verbal communication skills, collaboration and interpersonal skills.
- Proven organizational and administrative skills.
- Fluent in both oral and written English.
- Good time management skills and ability to prioritize tasks
- Willing to support people and team
- Ability to train others on study administration procedures.
- Ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Previous working experience in a Clinical Operations or Development Operations team under R&D
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Clinical Trial Assistant - Hong Kong, 香港 - AstraZeneca
描述
Senior Clinical Trial Assistant assists in the coordination and administration of local study activities throughout the entire study cycle to ensure quality and consistency of study deliverables to time, cost and quality objectives.
Senior Clinical Trial Assistant I provides administrative support to DeveOps team for any functional business activities.
Typical Accountabilities
Education, Qualifications, Skills and Experience
Essential
Desirable
【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。】
Date Posted
12-4月-2024Closing Date
29-9月-2024
