華鼎生技顧問股份有限公司

1.Experience in SDTM dataset, and ADaM dataset for FDA submission 2.臨床試驗資料統計分析 包含 PK analysis and Clinical analysis (PFS, OS..and so on) 3.熟悉SAS 程式 (Macro,glm..end so on.) 4.英文撰寫能力佳者 5.Develop and modify the statistical methodology. 6.Resolve malfunctions of SAS programs to ensure optimal analysis performance.Sample size and power estimation. 7.Design randomization schema. 8. Write the statistical analysis plan: detailed written specifications of statistics, tables and graphic displays. 9.Evaluate, analyze and report study data with expert statistical method: from routine t-tests to leading-edge, just-published methods. 10. Interpret statistical results and complete the statistical section of clinical trial report. 11.Conduct database lock, unlock, un-blinding process and data transportation process. 12. Conduct computerized error detection - “electronic edit checks”. 13.Produce simple tables and figuring in line with demand of statistical analysis and SAP specification. 14.Subject data listings generation. 15.Sample size and power estimation.

• Perform regular site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. Any concerns or ongoing issues should be escalated to the Project Manager or Clinical Research Manager, as appropriate. • Perform feasibility study survey to identify the potential sites or strong the business opportunity. • Prepare and submit respective visit report in a timely manner after every site visit. • Communicate with investigators to obtain necessary documentation and information before, during and after the study on an ongoing basis, to met quality requirements of central and investigator site files. • Support RA team by collecting investigator site regulatory documents for regulatory and ethics committee/IRB submissions. • If appropriate, assist in generation of Clinical Trial Agreements according to standard and local country practices, and assist the sites in agreement completion prior site initiation. • Initiate investigational sites to ensure that they have a complete understanding of the clinical protocol and that they could abide by their obligations to conduct a clinical trial as required by applicable regulations.

⚫Design CRF/eCRF and write CRF/eCRF guideline. ⚫ Rule test of EDC system. ⚫ Assure correctness of data captured in CRF in accordance with protocol specifications and GCP guideline. ⚫ Write validation plan as a rule of query issuing. ⚫ Create and issue the DQF and DCF to clarify any inconsistent or uncertain data recorded in CRF. ⚫ Check the data inventory and track status of every CRF/eCRF page and query. ⚫ CRF/eCRF correction according to the resolution from DQF and DCF. ⚫ AE and/or Medication coding. ⚫ Confirm the resolution of data issues for database lock.

1.協助行政事務(如文件影印與裝訂, 資料彙整, 聯絡試驗單位並收集所需文件, 申請付款/繳費等事宜) 2.協助送審文件準備 3.主管交辦事項 4.需具原住民身份

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜 3.需至各家醫院做臨床實驗

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.協助醫師執行臨床試驗 2.其他主管交辦事宜

1.英文資料KEY-IN,需具備英文讀、寫能力。 2.Conduct pCRF and query form log-in process. 3.Conduct data entry. 4. Flag any outstanding data entry issues for review. 5.Check and filing all the pCRF and query form. 6.Conduct documentation filing of data management and biostatistics files. 7.Assist the CRF database test. 8.Assist the rule test of EDC system. 9.Assist the rule design (Real-time edit check upload) of EDC system. 10.Assist generate the script and/or check the script for database testing.

1.臨床試驗專案管理。 2.臨床試驗co-monitoring visit執行。 3.臨床試驗進度及財務控管。 4.非主管職。  ESSENTIAL FUNCTIONS The Project Manager is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure the deliverables (timeline, quality, productivity) are met. The overall accountability for the execution of the clinical operations strategy on Project Manager has on the project.  KEY ACCOUNTABILITY 1. Client Liaison (1) Effectively communicate with internal and external customers as well as third party vendors. (2) Prioritize effectively and respond to urgent requests within team or from sponsor. 2. Project Initiation & Planning (1) Manage study start-up activities. (2) Provide input to project tools, project plan, central file maintenance plan. (3) Provide input to the format and content for sponsor reports. (4) Provide input to and oversight of site selection strategy plan. (5) Develop site selection and monitoring plans for the team. (6) Review and provide input into patient recruitment plan and retention plan. (7) Ensure all team members have access to tools and documents. (8) Establish efficient / effective working relationships with other functional leaders and coordinators across geographies and projects within a given program. (9) Develop study plans, tools and forms. 3. Project Implementation, Control & Evaluation (1) Provide leadership and direction to project team members. (2) Identify, organize and deliver (where appropriate) study specific training. (3) Evaluate and identify resourcing needs and continuously monitor over life cycle of project. (4) Provide productivity targets to project team members. (5) Provide performance feedback on team members as appropriate. (6) Address identified and escalated site issues and drive to closure. (7) Early recognize areas of potential problems and provide input to contingency plans. (8) Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project. (9) Oversee maintenance and quality check of Central Files. (10) Maintain and assure quality of work generated and escalate and follow up as appropriate. (11) Ensure appropriate handover between project team members. (12) Implement and instigate process improvements within the project. (13) Provide input to the Revenue Recognition forecast. (14) Identify changes in scope and liaise with Clinical Research Department & Business Development Department. (15) Participate in client, investigator and team meetings. (16) Prepare, participate in and follow up on audits / inspections. (17) Participate in all required applicable trainings. 4. Project Close-out (1) Collaborate with project team (e.g. BDM Leader) on database lock activities. (2) Together with Director of Clinical Research Department ensure all administrative closeout procedures are completed according to Project Close-out Checklist. (3) Ensure project is archived and all documentation returned to the client as specified by the contract. (4) Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant function.