Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
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? Then come and join our global team as a Clinical Research Associate 5 to drive multi-faceted projects within cross-functional teams from inception to launch.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what is possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what is possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Research Associate 5, you will be responsible for:
- Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop
- Manages clinical team to prepare for study initiation, execution and close out activities.
- Oversees development of clinical documents, including clinical plans, protocols, forms, and reports
- Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
- Manages and reports on study budgets
This position may best suit you if you have experience with the following, and would like to do develop your career with Healthineers:
- Experience working in a matrix organization with cross-functional teams to resolve issues that arise during clinical studies, a must
- 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
- Exposure to basic Project Management methods, knowledge of statistics would be an advantage
- Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements and client policies
Required skills to have for the success of this role:
- Bachelor’s Degree in a Biology, Chemistry, Biochemistry, Clinical Research, or related field
- 6+ years’ experience in managing clinical studies or equivalent product development programs
- Experience in in vitro diagnostic/medical device related studies is an asset
- Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices is desirable
- Advanced skills in project planning and management, judgment, decision-making and problem solving
- Exceptional communication skills
- Ability to prioritize and work independently
- High energy; driven; collaborative; highest integrity
- Travel requirements up to 30% in non-pandemic times
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.
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Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.
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
Full / Part time: Full-time
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