Clinical Affairs Specialist 4
Business Unit: Diagnostics
Requisition Number: 241257
Primary Location: United States-New York-Tarrytown
Other Locations: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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.
This is a role
well suited to an ambitious professional, looking for the next step in their
career. As a Clinical Research Associate 4 you will be responsible for:
- Under supervision of Clinical Affairs Sr. Manager or Project Manager, works with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to 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.
- With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated.
- 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.
- Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
- Knowledge of GCP and Human Subject Protection for the conduct of clinical trials
- Good knowledge of the in vitro diagnostics industry
- You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- You have very good presentation skills in the customer environment and you show team orientation, communication skills and customer orientation
- You have knowledge of regulatory requirements for in vitro diagnostic products
- Ability to work on multiple projects simultaneously.
Required skills to have for the success of this role
- Bachelor’s degree or equivalent experience required; three to five years related experience and/or training; or equivalent combination of education and experience.
- Ability to work with statistical concepts such as mean, standard deviation, %CV, correlation, agreement, p-values, contingency tables, ROC curves.
- Excellent communication skills, both verbal and written
- Willing to travel up to 25%
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.