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SHD Assistant Clinical Trial Manager

Job Description

Mission

Fast and efficient handling of clinical trials of designated products to be registered and sold in China.  Support CT Manager in all activities. 

Responsibilities:             

•            Develop and assess of clinical trials level feasibility, forecasting of timelines, estimation and allocation of resources and budget, and development of operational strategies.

•             Maintain an overview of status, issues, risks and proactively communicates progress, issues, changes or risk mitigation strategies that may impact timelines and costs of the project to CT manager.

•             Lead relevant responsible CRA/CRAs to plan and execute clinical trials to produce high-quality data on schedule in order to satisfy regulatory and registration strategy requirements.

•             Act as specific study leader for developing operation manuals/tools, performing co-monitoring visit, budget control and etc.

•             Contribute country specific aspects in the development of protocol, protocol revisions, amendments and CRF design.

•             Prepare and review clinical study agreements and budgets with CT manager and Contracts group.

•             Responsible for the management of designated sites in clinical trial, including but not limited at IRB/EC submission, investigator meeting/training, enrollment/testing, quality control, site closure, etc.

•             Be responsible for source data/documents verification/review, make sure the data/documents are attributable, Legible, contemporaneous, original and accurate.

•             Other related tasks assigned by supervisor.

Requirements:

University degree or above, major in medical/ biological/clinical or related.

Rich experience in CT within diagnositcs industry.

Adequate knowledge about diagnostics products and its major features, applications, and advantages.

At least 5 years clinical trial experience, knowledge in PRC regulations and rules.



Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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