新北市汐止區3年以上碩士以上
1. Prepare, organize, and manage the assigned studies (includes project of Regulations of Special Medical Techniques (Specific)) in accordance with regulations, Good Clinical Practice (GCP) and the Standard Operation Procedures (SOPs).
2. Provide strategic input into the feasibility, conduct site and/or vendor (e.g. CRO, central lab) survey and selection, and set up the study.
3. Develop the study management plan, including but not limited to the Communication Plan, Monitoring Plan (MP), Trial Master File (TMF) Plan, Recruitment Plan, Safety Reporting Plan and Risk Management Plan.
4. Develop the study documents, including but not limited to the protocol, Informed Consent Form (ICF), Case Report Forms (CRF), site tool, study flyer, and table of content of TMF/Investigator Site File (ISF).
5. Maintain and oversee the completeness of TMF at site, country and study level.
6. Oversee the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion, and data query generation and resolution.
7. Conduct Quality Control (QC) review of the study documents, including but not limited to the protocol, ICF, CRF, CRF completion guideline, Data Validation Plan
(DVP), Data Management Plan (DMP), laboratory manual, site tool, recruitment advertisement, regulatory submission package, and the site contract and budget.
8. Provide the study training to the internal team and/or vendor (if applicable) and drive the study execution among cross-functional teams.
9. Works with vendors to revise scope of service agreements, plans and detailed timelines, and negotiate the budgets.
10. Manage and oversee the vendors’ performance in adherence with the timeline, budget, and agreements; meanwhile, maintain the good collaborative relationships to ensure the successful delivery.
11. Present the study progress and project budget to senior management team and/or board meeting.
12. Plan and hold the investigator meeting for delivering the study target and building the rapport with site staffs.
13. Identify the study issues, implement the correction actions and prevention plans to mitigate the risks, and escalate to the appropriate parties.
14. Conduct the boost visit and present the study updates to the investigational sites, if required.
15. Manage study team assignments and resource allocation.
16. Take the line management responsibilities to the team members as assigned, such as the training, coaching, and reviewing performance. Perform the co-monitoring as necessary.
17. Assist in development and review of study workflow and SOPs.
18. Perform other duties as assigned by management team.
待遇面議