Philips Sr. Clinical Affairs Specialist in Shanghai, China

  • Keep updated with CFDA new regulations requirements; fulfill the Medical Devices Clinical Evaluation documentations of responsible registration products.

  • Clinical Trial Protocol, CRF, ICF review and finalization satisfying with CFDA regulations.

  • Participates in the identification of potential investigators and clinical sites conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

  • Participates in negotiating site/investigator grant within trial specific budget

  • Conducts clinical site initiation visits; advises and trains site personnel on Philips internal and regulatory requirements for clinical trial conduct; participates and/or conducts site meetings

  • Verifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.

  • Verifies that site facilities, including laboratories and equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.

  • Responsible for trial materials distribution and accountability

  • Monitors and reports trial progress and ensures timely subject recruitment and trial completion.

  • Conducts site monitoring visits and follow-up to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulatory requirements, GCP guidelines and SOPs.

  • Identifies trial site problems and initiates/implements corrective actions.

  • Ensures high quality CRF/EDC completion in a timely manner and performs source data verification

  • Ensures that the receipt, use and return of the investigational product(s) at the trial sites are controlled and documented adequately

  • Performs trial document management and ensures both trial / site specified TMFs and Investigator Folders are completed according to CFDA GCP, ISO14155, ICH GCP and internal SOPs.

  • Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs.

  • Ensures the investigator payments are processed according to study site budget plan and clinical trial agreement with the investigator.

  • Provide co-monitoring to CRAs to ensure study quality.

  • Performs miscellaneous job-related duties as assigned.

Knowledge and skills required

  • Bachelor's degree in the fields of Healthcare Sciences plus minimum 3 years of working experience and in which at least 2 year Clinical Trial relevant working experience.

  • Knowledge of GCP and understanding of national regulations essential

  • Good self-motivation and self-organization

  • Good interpersonal skills, diplomacy and the ability to motivate and organize other

  • Fluency in both verbal and written English essential

  • Computer literacy essential

  • 30-50% travel required