Posted on Oct 12th 2019

Clinical Study Manager

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

376746

保存职位

Job Title

Clinical Study Manager

Job Description

In this role, you have the opportunity to

work with talented research team in Philips Research China, while closely collaborating with local clinical partners, global research community and business within Philips.

You are responsible for

  • Take primary responsibility to coordinate, oversee and execute the end-to-end study process for the study portfolio consisting of all study types as assigned by the Innovation Program Managers (IPMs) in the cluster-specific Study Affairs Meetings (SAMs). The study manager is a formal team member in each of the study portfolio’s research teams.
  • Serve as a full member of the SAM, specifically with regard to the strategic prioritization, study status tracking and management of his/her study portfolio.
  • Take responsibility for study-specific document submissions, amendments and closure as required by the Internal Committee for Biomedical Experiments (ICBE).
  • Liaise with Clinical Study Managers and other staff in the Clinical Operations group with regard to international and national regulatory and compliance requirements of clinical studies, including clinical investigations.
  • Provide guidance to Project Leaders, Scientists, Researchers and Research Engineers in the project teams with regard to internal and external process requirements.
  • Liaise with internal and external role players, where applicable, to contribute to the strategic continuity of project-specific objectives and priorities, including ICBE Secretaries, Clinical Research Board, study monitors, clinical site staff and third party vendors. In the case of study monitoring, it may involve responsibility for the development of the monitoring plan, training of investigators and site staff on the protocol, scheduling monitor visits and study amendments in close collaboration with the formal study monitor.
  • Manage the timely reporting of CAPAs linked to project-specific violations. This involves participation in the relevant CAPA Review Board.
  • Responsible for the reporting of Serious Adverse Events, where applicable, to internal and/or external role players in line with the applicable laws, regulations and standards.
  • Participate in internal and external project audits, where applicable.

You are a part of

Philips Research, which is the essential force of end to end innovation. Philips Research China was established in 2000. Research department Precision Diagnosis and Image-Guided Therapy (PD/IGT) is working on the innovation for ultrasound, CT, MRI and IGT.

You will report directly to the department head. You will have close interaction with global research team, relevant local/global Business and healthcare professionals.

To succeed in this role, you should have the following skills and experience

  • Bachelor degree in life sciences or related medical/scientific field. Advanced degree (Masters or PhD) in life sciences or related medical/scientific field is preferred.
  • Minimum of 5 years of research experience in a relevant medical device technology research field, including experience in conducting data studies, market research, animal studies and medical device clinical studies.
  • Experience in one or more of the following research fields is a plus, ideally in diagnostic imaging, image-guided therapy, acute care signal processing, clinical informatics and medical device research.
  • Project management skills, including strong problem solving skills, quality focus and change management skills.
  • Experience in lean and agile ways of working.
  • Demonstrated ability to work effectively in cross-functional and geographically diverse teams, including the ability to plan and facilitate face-to-face and digital meetings.
  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
  • Currently valid Good Clinical Practice (GCP) training certificate and experience in GCP.
  • Knowledge of ISO 14155 and ISO 14971standards and requirements is a strong plus.
  • Experience in working with the following software tools: SharePoint, Windchill, ORION-ICBE is a plus.
  • Experience in the legal and commercial aspects relating to contracting in general, and contracts in the life sciences arena, in particular, is a plus.

In return, we offer you

A path towards your most rewarding career. Succeeding in this role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. You will be working with a group of talented scientists who have passion to deliver meaningful innovation in imaging system.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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