SHD RA Clinical Trial Leader

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

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

Your tasks and responsibilities:

1.      Contribute to the development and assessment of program level feasibility, forecasting of timelines, estimation and allocation of resources and budget, and development of operational strategies.

2.      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 program to all stakeholders.

3.      Can work closely with global medical and clinical teams to plan and execute clinical studies to produce high-quality data in order to satisfy regulatory requirements.

4.      Be responsible for working with multiple clinical partners and vendors to complete clinical trials.

5.      create standard operating procedures, clinical study monitoring, and data acquisition.

6.      Evaluate and implement optimal outsourcing models. Lead the operations team in the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution and ensure proactive management of CRO to deliver within established timelines, budget, and quality expectations.

7.      Develop and implement processes across all operations functions and ensure proactive inspection readiness.

8.      Contribute to authoring clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs)and responses to NMPA' questions.

Your qualifications and experience:

1.      Read, write and speak fluent English; excellent verbal and written communication skills

2.      Must have a thorough knowledge of clinical research concepts, practices, and NMPA regulations

3.      Must have prior experience managing a clinical trial portfolio or large scale clinical trial program and be able to demonstrate a proven track record of successfully leading cross-functional projects in a global environment.

4.      The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically

5.      Strong resource integration competency

6.      Bachelor’s required, Master’s preferred

7.      Overseas education and oversea clinical trial operations experience preferred

8.      A minimum of 10 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device and/or CRO industry is required. IVD experience preferred

9.      Five or more years of clinical program line management experience at a sponsor or CRO company

Our global team:

Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture:

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

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 Diagnostics (Shanghai) Co., Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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