南京招聘

职责描述：

-Function as a project leader to manage and coordinate clinical research projects and related medical affairs.

-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 CFDA 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.

-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.

- Assist the Sr. Clinical Research Manager in building the MSA network and additional responsibilities as required

任职要求：

-Bachelor/master in Medical, Pharmaceutical, Biomedical

-Fluent in English

-Office (project management)

-Total working experience 8+Y (5+ Y Sr. CRA experience, 3+Y project management)

-Clinical trial experience in Medical Device/Pharmaceutical

-CRO experience is preferred

-GCP Certification, Project Management certificate is preferred

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