宜昌招聘

职位描述：
? Plan, propose, manage Clinical Research projects according to Medtronic MITG’s product registration plan, and ensure timely completion
? Prepare and finalize study protocol in Clinical Research including protocol design, statistical analysis, etc.
? Prepare binders to Ethical Committee in Hospital for board review in Clinical Research projects
? Prepare and finalize study report in Clinical Research projects
? Manage all Investigator Sponsored Research (ISR) projects and the whole process from initiation till completion
? Visit principal investigator when protocol queries/comments in ISR application need to be clarified
? Communicate with GBU about Clinical Research projects and maintain fluent communication and information delivery across GBU and regional
? For clinical studies with registry purpose, submit dossiers to Regulatory Affairs team about clinical data and ensure the submitted documents are in accordance with regulatory requirements
? Manage post-market survey or surveillance studies with the same standard practice as clinical study
? Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
? Serve as primary project contact of the clinical team to ensure communication is maintained with all relevant stakeholders.
? Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
? Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
? Provide input for the development of project budgets.
? Provide input to line managers (if applicable) of their project team members' performance relative to project tasks.
? Prepare and present project information at internal and external meetings.
? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA.

? Bachelor's degree in life sciences or related field and 6 years or above clinical research experience including 3-5 years project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
? Good therapeutic and protocol knowledge
? Strong communication and interpersonal skills, including good command of English language
? Good problem solving skills
? Demonstrated ability to deliver results to the appropriate quality and timeline metrics
? Good teamwork skills
? Excellent customer service skills
? Good presentation skills
? Good judgment
? Strong software and computer skills, including MS Office applications
? Ability to establish and maintain effective working relationships with coworkers, managers and clients 举报 分享

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.