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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.

• 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

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