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We are currently looking for an ambitious Principal Clinical Research Development Specialist to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.
As a Principal Clinical Research Development Specialist, you will be responsible for:
Clinical study design for industry sponsored clinical trials for new products and expanded indications.
Ensuring all clinical research activities comply with regulatory requirements (FDA, EU, ICH-GCP) and institutional policies.
Assisting in the preparation and submission of regulatory documents, including IDE, IRB applications, informed consent forms, and safety reports.
Addressing and resolving any data discrepancies or issues that arise during the research process.
Developing and delivering training programs to prepare the clinical operations team to implement the study protocols.
Staying updated on industry trends, regulatory changes, and advancements in clinical research methodologies.
Providing leadership and mentorship to the organization, fostering a culture of excellence and compliance in clinical research.
Additional duties and tasks as identified.
This position may require occasional travel, estimated at 10% [domestic and/or international], depending on project needs and organizational requirements.
Required skills to have for the success of this role:
Master's degree in a relevant field (e.g., Clinical Research, Life Sciences, Public Health), PhD strongly preferred. Relevant certifications (e.g., Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) are preferred.
Minimum of 10 years of experience in clinical research, with at least 5 years in relevant industry sponsored trials and 5 years of strategic leadership role.
Demonstrated experience with regulatory compliance and clinical trial management in the US and OUS.
Experience with regulatory body (e.g., FDA) collaboration.
Experience in regulatory submissions (e.g., IDE, De Novo)
In-depth understanding of clinical research regulations, Good Clinical Practice (GCP), and industry standards.
Familiarity with industry standard data management systems and research methodologies.
Self-starter who takes the initiative with a sense of urgency.
Excellent communication, organizational, and problem-solving abilities.
Who we are: We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://jobs.siemens-healthineers.com/careers
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