Sr. Clinical Manager

Date:2022-04-06

Job Responsibility:

  • Perform study start-up activities, including study plan build-up, study protocol and CRF design, Investigator Meeting, EC and MOST approval, site selection, site initiation, E-Trial development, co-monitoring, study closure and other related activities ensuring compliance with NMPA regulation, GCP/ICH guidelines and company SOPs.

  • Allocate the budget by project and conduct the daily management and update the usage status.

  • Document and updated the progress of assigned clinical studies through regular status report.

  • Provide direction and oversight of outsourced activities to ensure Clinical Research Organization (CRO) and vendors delivery against contracted scope of work.


Qualification:

  • Bachelor or master in medical.

  • 8 years clinical research experience, 5 years people management experience.

  • Open minded, Able to work under pressure, Strong organizational, communication skill, high degree of accuracy and attention to detail.

  • Collaborate with cross functional department such as Global Medical Science Affairs, Regulatory Affair, Sales & Marketing, IT, Finance and Legal to support project milestone achievement. Provide clinical Trial dossier for registration use.

  • Coordinate Medical Affairs tasks such as Post Marketing clinical Projects, clinical Evaluation Report, publication. D1520.

  • Understanding GCP.

  •  Fluent in English.


Location:

Shanghai, China

Email to:

hr@wallabymedical.com

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