Philips Clinical Trial Manager in China
Clinical Trial Budget, Timeline, quality control planning.
Trial Essential documents preparation such as Protocol, CRF, ICF draft/finalization coordination.
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
Co-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
Co-erifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.
Co-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 coordination.
Oversee and reports trial progress and ensures timely subject recruitment and trial completion.
Oversee the 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 with the site monitors.
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 that the monitoring visit reports after each trial-site visit or trial related communication done by the site monitors.
Ensures the investigator payments are processed according to study site budget plan and clinical trial agreement with the investigator.
Performs miscellaneous job-related duties as assigned.