Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. 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. This is what truly matters to us.

Join our team now at Siemens Healthineers as Clinical Affairs Specialist 2

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Affairs Specialist 2, you will be responsible for:

• You will aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, statistical data analysis plans, and associated study data collection forms.
• You must remain current with regulatory requirements for in vitro diagnostic products.
• With some supervision, you will assist in all activities related to the set-up, initiation, execution, and close-out of in vitro diagnostic device clinical trials including sample collection, timely review and analysis of data generated.
• You will help during virtual and on-site monitoring visits to ensure protocol compliance, accuracy, and completeness of clinical data.
• You must communicate with study investigators via phone, email and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
• You will participate in coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
• You will support the preparation of up-to-date clinical study progress reports.
• You will support the tracking of study budgets, site contract origination, compliance approval and execution.
• You will assist the Clinical Affairs Supervisor with preparation of responses to regulatory agencies.
• You will assist in the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies.
• You will assist in departmental administration as needed i.e. freezer inventory management, monitoring training compliance, tracking of clinical trial site traffic.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

• You have knowledge of IVD assay design and development.
• You have basic data analysis skills.
• Willingness to travel 20%
• You have experience conducting remote clinical trials

Required skills to have for the success of this role

• Bachelor’s degree or equivalent experience required
• Must be willing to travel 20%

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.