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Clinical Research Associate 5

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 60,000 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.  

Clinical Research Associate 5

• Represents Clinical Affairs on multifunctional Product Development Teams assigned development of high complexity or novel products. Able to assess data and status of products throughout the development cycle and relate to risk of clinical trial success. 

• Responsible for updating function based on progress of Product Development Core teams and escalating issues that could impact product development timelines or budgets.

• 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. 

• Supervise junior CRAs assigned to support clinical studies for Product Development Teams

• Supervises and assures 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. 

• Independently schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.

• Communicates with study investigators via phone, fax, 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.

• Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.

• Responsible for monitoring and preliminary analysis of test data. Capable of assessing precision, accuracy, and identifying trends in data.

• Provides up-to-date clinical study progress reports.

• Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution. Leads negotiations with CROs for large or specialty studies.

• Completes the tracking of budgets for studies.

• Remains current with regulatory requirements for in vitro diagnostic products.

• Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies. 

• Represents Clinical Affairs on multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies. Capable of drafting scientific abstracts.

QUALIFICATIONS AND REQUIREMENTS

• BS in a related scientific field required.

• High energy; driven; collaborative; highest integrity.

• Knowledge of in vitro diagnostic product design and development and experience as a member of product development core teams preferred.

• Awareness 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.

• The ability to work in a matrix organization with cross-functional teams is required.

• Excellent communication skills in person and virtually with presentations, and both oral and written required.

• Travel requirements up to 30% in non-pandemic times

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.

(Note: Accommodations may be requested for certain medical or religious reasons)


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.

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