In this role, you have the opportunity to
• Do the operational execution of clinical study involving humansubjects from its inception to close-out.
• Ensure robust an******** clinical plans are developed; the consistentan******** communication of clinical plans, project tracking an********,to all internal an******** stakeholders;
• Manage Contract Research Organization overs******** including staff;coordination of site v******** review reports an******** adequatecorrective action;
• Develop Clinical Evaluation Report (CER) per needs.
You are responsible for
• Ensure all the company-sponsore******** execute******** compliancewith GCP, relate********, Philips harmonize******** SOPs in terms ofquality an********;
• Ensures the clinical study successfully complete on time an******** budget;
• Ensures the clinical study in high quality an******** to Philipsharmonize******** SOPs an******** regulation;
• Ensures the clinical study can withstan******** scrutiny by internalclinical trial audit or Regulatory entity where the risk of failure canaffect product registration;
• Ensures that all internal an******** collaborating staff areappropriately organ******** traine******** manage******** execute theterms of a research project per protocol an******** ensure studyan******** integrity in support of a broader Clinical Evidence Strategy;
• Actively interfaces with various internal an******** stakeholdersincluding clinical science teams, internal customers, Regulatory, Legal,******** CRO/vendor staff, Key Opinion Leaders an******** research staffas the subject matter expert for clinical GCPs;
• Proactively identifies an******** prepares high quality clinical trialexecut******** project management, an******** documentation (Protocol,Investigator Brochure an******** Consent Form).
• Provide leadership in standardizing an******** clinical-relate********to Ethics Committee;
• Develop Clinical Evaluation Report (CER) per needs.
You are a part of
Great China Q&R team
To succee******** this role, you shoul******** the following skills an********
• Self-motivate******** who is able to manage multiple tasks an********in an efficient manner.
• Demonstrate******** recor******** Compliance to regulations governinghuman clinical research.
• Demonstrate******** of GCP an******** regulatory requirements for theconduct of research involving human subjects is require********communication an******** team skills.
• Comfortable working closely with a team taking ownershi******** wherenee******** an********/delegating task appropriately.
• Total Site Management, Bu******** Agreement negotiation experience is required.
In return, we offer you
A path towards your most rewarding career. Philips is growing itsmarketing capability enterprise wide. Succeeding in thismarket-base******** in a complex environment will open many doors foryour long term career, in other areas in Philips or otherwise. We alsobelieve that we are at our bes