Philips Clinical Operation Manager in Beijing, China
The Clinical Operation Lead is responsible for the best practice of operational execution in the conduct of clinical study for the purpose of validating product Safety and Efficacy for pre-market approval, claims substantiation and/or to fulfill post-market requirements, when applicable.
Ensures the clinical study successfully complete on time and on budget.
Ensures the clinical study in high quality and compliant to Philips harmonized clinical SOPs and local regulation.
Ensures the clinical study can withstand audit scrutiny by internal clinical trial audit or Regulatory entity where the risk of failure can affect product registration.
Ensures that all internal and external collaborating staff are appropriately organized, trained and managed to execute the terms of a research project per protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
Actively interfaces with various internal and external stakeholders including Clinical Affairs management team and clinical science teams, internal customers, Regulatory, Legal, Quality, CRO/vendor staff, Key Opinion Leaders and clinical research staff as the subject matter expert for clinical GCPs
Coordinates and streamlines the clinical research workflow in order to support the clinical deliverable.
Obtains approval to conduct clinical trials of investigational equipment.
Proactively identifies and independently prepares high quality clinical trial execution, project management, and reporting documentation (Protocol, Investigator Brochure and Inform Consent Form)
Clinical Operation Manager
In this role, you have the opportunity to
Lead and develop the clinical operation team in China to ensure clinical study successfully complete on time, on budget, in high quality and compliance with regulatory requirement
Independently lead studies to develop accomplish milestones on time and ensure compliance to requirements and procedures
Proactively address possible risks and effective communication of risks if applicable
Quality of studies successfully completed on time, on budget
Quantity and complexity of studies successfully completed on time, on budget
Customer, stakeholder and peer satisfaction
Demonstrate subject matter expertise across all aspects of clinical trials from planning, execution to conclusion.
You are responsible for
Managing a part of a business process or function.
Manages activities of two or more sections. Exercises supervision in terms of costs, methods, and staffing.
Strong influence on Business magnitude: > € 30 M.
You are a part of
Great china Q&R team
To succeed in this role, you should have the following skills and experience
Bachelors or Advanced Degree in Medicine or life science education background
At least 10 years’ experiences in clinical development and/or medical affairs of pharmaceuticals and/or medical device industry
At least 3 years ’people management experience
Demonstrated track record of Compliance to regulations governing human clinical research.
Demonstrated expertise of GCP and CFDA regulatory requirements for the conduct of research involving human subjects is required.
Effective organizational, communication, and project team skills.
Experience in developing and/or implementing Clinical Research SOPs in an industry setting
Total Site Management, Budgeting, Agreement negotiation experience is required.
Must be able to interpret complex Clinical Trial Datasets.
Must have a demonstrated track record of working with diverse platforms of Data Collection.
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.
A professional but fun workplace, A healthy work-life balance environment;
An energetic, genuine, inventive, supportive and dynamic team atmosphere;
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .