诺华公司

Job Description

• Assists Medical Advisor in determining the feasibility of conducting the clinical trial and preparing relevant documents.

• Takes an active role in the internal project management group in working closely with medical advisor, drug registration officer and brand manager.

• Responsible for the identification of potential investigators and clinical sites.

• Coordinates Regulatory Authority and Ethics Committee applications and approvals

• Responsible for study drug management, including the distribution of trial supplies, including trial medications. Liaises with local depot to ensure timely and reliable trial materials distribution and accountability.

• As the key responsible person of Novartis for projects that is contracted out to 3rd party (e.g. CRO) to implementation, ensure the projects to be conducted according to GCP and Novartis relevant SOPs.

• Develops trial subject recruitment strategies and plans.

• Assists to organization of investigator meetings and chairs regular internal trial management meeting.

• Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs and coordinate communication with local CS&E.

• Provides monthly trial progress report to relevant stakeholders

• Ensures the investigator payments are processed according to trial budget plan.

• Assists investigator to ensure the accuracy and completeness of TMFs when trial close.
Minimum requirements
BS or higher degree with medical or pharmacological background