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SHD Clinical Trial Specialist

Job Description

Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. 

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.

Our global team:

We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. We aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

 

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

 

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.



Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Full / Part time: Full-time

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