倍思大生技股份有限公司

1.Review, develop, and maintain regulatory documents and safety databases 2.Conduct PV: receiving, processing, submitting, maintaining safety cases/regulatory data, and medical coding 3.Establish and facilitate communication with study sites, the EC/IRB, and health authorities 4.As appropriate, assist Bestat and relevant parties in facilitating medical monitoring and regulatory processes, management, and policies

1. Design CRF based on study protocol and prepare the CRF completion guideline. 2. Generate data management plan and data validation plan. 3. Clinical Data Management / Clinical data management status report. 4. Provide training to the site personnel and reporting agencies on proper data collection processes. 5. Coordinate with clinical monitoring activities to help provide prompt feedback to sites on data quality. 6. Establish data quality standards and works with reporting agencies to ensure standards are met. 7. Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.

工作內容： 1.參與及協助臨床試驗相關計劃的送審、執行、監督及回報。 2.臨床試驗相關個案報告整理及追蹤。 3.協助臨床試驗監測及病人收案。 4.定期出差至醫院執行試驗監測、確保試驗收案符合預期、臨床試驗執行符合GCP、計劃書與相關法規規定。 5.醫院IRB各項行政與業務處理和維護、相關事務溝通協調 6.提供PI/Site選擇之評估建議與回饋。。 7.其他主管交辦事項。 工作型態： 需要出差到試驗單位(醫院)，查看臨床試驗的進度，並定期回報給臨床研究經理(CRM)，出差天數依據試驗案的進程而定。

1. Draft, review, and finalize clinical study documents in compliance with ICHGCP, applicable regulatory guidelines, and sponsor specifications, including but not limited to: ▪️Clinical study protocols and protocol amendments ▪️Investigator’s brochures (IB) and IB updates ▪️Clinical study reports ▪️Informed consent forms ▪️Briefing documents for regulatory meetings ▪️Patient narratives and safety summaries ▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7) 2.Ensure scientific accuracy, clarity, and consistency of content across all documents 3.Collaborate cross-functionally with biostatistics, data management, clinical operations, medical affairs, pharmacovigilance, and regulatory affairs teams Interpret statistical and clinical data for integration into reports and summaries 4.Follow internal SOPs, writing style guides, and client-specific templates or standards 5.Maintain awareness of current regulatory requirements and industry best practices in clinical documentation 6.Assist in developing and maintaining document timelines, ensuring timely delivery 7.Respond to quality control or medical/scientific review comments and incorporate revisions accordingly 8.Hold PI meetings, and present protocols and clinical trial results to PIs and relevant personnel 9.Undertake other MA-related tasks as assigned by the line manager