Posted on Oct 12th 2019

Clinical Quality Leader

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

439369

保存职位

Job Title

Clinical Quality Leader

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to

· Provide leadership in execution of clinical studies to deliver high quality data to support Philips on time, within budget and in compliance to all applicable regulations and Philips procedures
· Drive adoption of compliant clinical study execution practices throughout Philips active in clinical studies including research and testing of products involving human beings
· Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
· Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting.
· Hire, manage, and motivate Clinical Operations Staff.

You are responsible for

· The Clinical Operations Clinical Quality Leader is responsible for ensuring compliance to regulations, guidance and Philips requirements for execution of clinical studies.
· May support internal and external audits through audit preparation, site and Philips file review, back room audit support, and support of CAPA
· Engages with Philips entities who perform clinical studies to ensure they are trained in GCP, clinical study process and procedures, and tooling such as EDC and CTMS as applicable.
· Reviews clinical documentation to ensure it abides by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit (such as FDA).
· Periodically interfaces with various internal and external stakeholders such as audit, legal, regulatory, quality, and privacy.
· Supports evaluation and implementation of Clinical and Medical Affairs IT systems to ensure appropriate user requirements, user stories, testing and validation documentation.

You are a part of

Clinical operations team, ensure execution of clinical studies is conducted according to Philips requirements, applicable regulations, and guidance

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

· BS/BA in scientific or relevant discipline.
· Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner.
· Must be able to communicate effectively across a diverse global network of businesses and be comfortable in a virtual environment.
· Ideal candidate has 5+ years of experience leading or overseeing clinical research in drug/device industry.
· 7+ years training investigator sites, independently conducting monitoring visits, and assessing protocol compliance.
· Comfortable working closely with a team taking ownership/initiative where needed, and taking/delegating tasks appropriately.
· Demonstrated expertise of GCP, ISO and FDA regulatory requirements for the conduct of research involving human subjects is required.
· Must be proficient at using Microsoft Office.
· Experience with Electronic Data Capture platform is preferred.
· Prior certification (such as SOCRA, RAPS, CCRA*) strongly preferred

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based 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.

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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