工作種類
- 研發
專業
- 生物化學
- 生物資訊學
- 生物科學
- 生物學
- 生物醫學科學
- 生物科技
- 細胞及分子生物學
- 生態及環境科學
- 食品及營養科學
- 醫療保健
工作經驗
- 4-6年
職位詳情
工作描述
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.
職責
- 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
入職條件
Essential
- 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.
Desirable
- 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
關於公司
概述
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.