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Philips Clinical Affairs Manager in Shanghai, China

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Job Description-Clinical Affairs Manager

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; the consistent and effective communication of clinical plans, project tracking and completion, to all internal and external stakeholders;

  • Lead the clinical evaluation projects across the product lines, work closely with Regular 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; Work closely with principle investigator to conduct clinical research as a qualified researcher per need. You are responsible for

  • Proactively address possible risks for study data for regulatory submission and effective communication of risks if applicable;

  • Satisfaction level from CFDA for clinical evaluation report and clinical trial documentation or data;

  • Demonstrate subject matter expertise for clinical evaluation and clinical trial data interpretation;

  • Develop Clinical Evaluation Report (CER) per needs;

  • Ensure all the company-sponsored studies executed in compliance with GCP, related regulations, Philips harmonized clinical SOPs in terms of quality and timeframe;

  • 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 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;

  • Proactively identifies and independently prepares high quality clinical trial execution, project management, and reporting documentation (Protocol, Investigator Brochure and Inform Consent Form). You are a part of Great China Q&R team To succeed in this role, you should have the following skills and experience

  • Master or PhD in medicine or life science education background;

  • At least 2 years in Clinical Evaluation;

  • At least 3-5 years in Clinical Trial project management;

  • Demonstrated expertise in CFDA regulatory requirements and data interpretation;

  • Demonstrated expertise in GCP 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;

  • Medical affairs experience in medical device company preference.

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