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Clinical Affairs Specialist 2

Company: Siemens Corporation
Location: Newark
Posted on: June 8, 2021

Job Description:

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 Research Associate 2 This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Research Associate 2, you will be responsible for: In your activities you will aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. You will supervise study sites and activities also during on-site visits to ensure adherence to protocols and terms of the study You will communicate with study investigators regarding activities in all phases of the studies including study budgets, contracts and their approvals by compliance and IRBs You gained knowledge of in vitro diagnostic product design and development and experience as a member of product development core teams preferred. You are aware of US (21 CFR 820) and EU (ISO 13485) quality system requirements; Understands: Design Control, Good Clinical Practice, In Vitro Diagnostic Regulation, Essential Requirements, labeling requirements, and regulatory requirements of pertinent regions. You show the ability to work in a matrix organization with cross-functional teams. You show excellent communication skills in person and virtually with presentations, both oral and written. Required skills to have for the success of this role Bachelor's degree or equivalent experience required Willing to travel up to 30% 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. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here.

Keywords: Siemens Corporation, Newark , Clinical Affairs Specialist 2, Other , Newark, Delaware

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