资深流程和培训经理 Sr. Process & Training Manager

Job description

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Job Summary

·  Following CNDA regulations, company SOPs and Divisional Standards required by headquarter, provide direction, leadership and management of the local clinical operation process and ensure the consistent interpretation and effective implementation of quality standards applying risk management in Clinical Study conducted by local operation;
·  Liaison with global counterparts, assist the development and adoption of IT tools of clinical operations, and provide training of the system and process to local operation team;
·  Administratively manage the data management, biostatistics, and central document management functions, and coordinate cross-functional projects;

Main Tasks & Responsibilities:

·  Provide training, leadership and process management to the local clinical operations team
·  Provide process and training strategic direction in line with the global SOPs and local regulations
·  Quality and risk management – lead the implementation of local quality risk management and inspection readiness approaches
·  Develop and adopt the IT systems and tools to facilitate and standardize the local clinical operation process, together with the supports of local IT and global counterparts
·  Administratively manage the data management, biostatistics, and central document management functions, to facilitate and standardize the local clinical operation process
·  Develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects
·  Conduct Other projects or tasks assigned by line manager
·  Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

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