Clinical Affairs Project Manager Job (Wuxi, JiangSu, China)
- Plan, implement and drive all aspects of clinical studies in compliance with GCP, (Good Clinical Practice,) the RMP, (Research Management Procedure,) Work Instructions, Corporate Policies, Guidelines and internal Standards.
- Manage cross-functional team, facilitating the team's ability to fulfill their responsibilities in accordance with project specifications and regulatory, GCP and GEHC requirements
- Manage day-to-day operational aspects of assigned projects including third-party vendor activities.
- Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
- Responsible for the timely and accurate completion of project documentation, such as protocols, amendments, case report forms and study report, stored appropriately and audit-ready.
- Develop and maintain close working relationship with Research Manager to ensure client satisfaction, operational and customer service excellence.
- Manage, maintain and accurately forecast study team requirements, clinical project subject enrollment and timelines, ensuring high level of data and image quality
- Interfaces with Regulatory Agencies as required.
- Ensures overall regulatory compliance of investigational sites with applicable regulations.
- Actively involved in Research process improvement activities/projects.
- Actively involved in Corrective and/or Preventive actions tied to Research process.
- Educate GEHC research teams on Good Clinical Practice guidelines, GEHC Research Management Procedure and applicable laws and regulations as they apply to research study.
- Effectively and succinctly communicate MACA organization mission/vision and value to business.
Quality Specific Goals:
1. Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required.
4. Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures.
5. Assist with continuous improvement activities by driving the implementation of process improvement initiatives.
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