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- 职位介绍
- Role Summary/Purpose : The clinical affairs project manager is responsible for one or more clinical research studies. As the team leader, the Clinical Affairs Project Manager will provide the study team with the overall direction, clear expectations for deliverables and the leadership necessary for the successful management, conduct and completion of a clinical study program. Essential Responsibilities : 1. Plan, implement and drive all aspects of clinical studies in compliance with GCP (Global Clinical Practice) the RMP (Research Management Procedure) Work Instructions, Corporate Policies, Guidelines and internal Standards. 2. Manage cross-functional team, facilitating the team’s ability to fulfill their responsibilities in accordance with project specifications and regulatory, GCP and GEHC requirements 3. Manage day-to day operational aspects of assigned projects including third-party vendor activities 4. Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects 5. 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 6. Develop and maintain close working relationship with Research Manager to ensure client satisfaction, operational and customer service excellence 7. Manager, maintain and accurately forecast study team requirements, clinical project subject enrollment and timelines, ensuring high level of data and image quality 8. Interfaces with Regulatory Agencies as required 9. Ensures overall regulatory compliance of investigational sites with applicable regulations 10. Actively involved in Research process improvement activities/projects 11. Actively involved in Corrective and/or Preventive actions tied to Research process 12. Educate GEHC research teams of Good Clinical Practice guidelines, GEHC Research Management Procedure and applicable laws and regulations as they apply to research study 13. Effectively and succinctly communicate MACA organization mission/vision and value to business Qualifications/Requirements : 1. Aware of 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 defied deadlines 3. Identify and report and 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 Desired Characteristics : 1. Bachelor’s degree in a life sciences related field or R.N. plus a minimum of 2 years clinical research experience, OR a minimum of 5 years progressive experience with clinical research 2. Clinical Research experience to include of all aspects of the clinical research process, including: site selection; investigator qualifications; monitoring as a Sr. or Lead CRA; protocol and report wiring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.) 3. Minimum 1 years’ experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate * evaluate deliverables; as well organized and structured, strong attention to detail 4. Ability to travel up to 25% of time of job related responsibilities
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