Associate Clinical Affairs Manager

3 weeks ago


Shanghai, China Philips Full time
JOB DESCRIPTION

Job Title

Associate Clinical Affairs Manager

Job Description

In this role, you have the opportunity to

· Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;

· Lead the clinical evaluation projects across the product lines, work closely with Regulatory team, product team, marketing team to develop robust and rational clinical evaluation strategy; Ensure the clinical evaluation projects successfully accomplished on time and on quality;

· As key scientific reviewer to assess the scientific and ethical of the company sponsor study & IIS;

You are responsible for

• Participate in the evidence generation processes for NPI & LCM

• Participate in the CDMA(Clinical Development and Market Access) process

• Participate in the development of clinical deliverables, including clinical evaluation reports, clinical trial protocols, CSRs & clinical sections of regulatory submissions

• Working closely with Clin Ops and BS&DM on day to day management of assigned clinical studies

• Supports clinical literature searches and reviews



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