Siemens Healthineers AG | Principal Clinical Research Development Specialist
2 days ago
Apply locations PAO H time type Full time posted on Posted 5 Days Ago job requisition id R-18674
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. Sustainably.
At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Our Global Team:We are a team of more than 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s 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’s 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.
Responsibilities:- Completes the development of study protocols including risk rationales and/or advising the company on the appropriate study design.
- Coordinates and leads the development of study protocols including risk rationales and/or advising the company on the appropriate study design.
- Coordinates the implementation of clinical and preclinical studies according to protocol and regulatory guidelines.
- Manages the preparation of clinical and preclinical portions of regulatory submissions.
- Ensures that proper local approvals are obtained and agreements are executed prior to the start of the clinical study.
- Performs and/or trains on the implementation and conduct of clinical and preclinical studies.
- Assures data are collected in a timely and cost-effective manner and is consistent with regulatory standards.
- Coordinates the communication with regulatory authorities and Ethics Committees for the application for clinical studies.
- Designs and conducts pre-study collaborative meetings with investigative and regulatory agencies.
- Completes the tracking of contracts/budgets for the studies.
- Completes clinical and preclinical regulatory submissions to support study data.
- Trains and implements clinical monitoring, including negotiations and coordination of 3rd party organizations.
- Conducts study initiations and close-outs.
- Trains and reviews the documentation of clinical evidence for regulatory purposes.
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.
The base pay range for this position is Min $157,500 - Max $236,200. Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.
This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
Beware of Job Scams: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.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
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