Clinical Affairs Professional
Siemens Healthcare Diagnostics Inc.

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Apply now for the position of Clinical Affairs Professional and, if successful, you will join a global team focused and dedicated to conduct IVD clinical studies in collaboration with external partners to deliver comprehensive, high-quality data for regulatory clearance.

Your role:

• You coordinate the implementation of clinical studies according to protocol and regulatory guidelines, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• You ensure that proper local approvals are obtained, and agreements are executed prior to the start of the clinical study.
• You train external partners on the design, execution, and protocol compliance of clinical studies.
• You assure data are collected in a timely and cost-effective manner and is consistent with regulatory standards.
• You coordinate the communication with regulatory authorities and Ethics Committees for the application for clinical studies.
• You complete the preparation and tracking of contracts/budgets for the clinical studies.
• You train and implement clinical monitoring, including tracking of patient recruitment, case report form (CRF) completion, and data query resolution.

Your expertise:

• You possess a bachelor's degree in life science or other scientific discipline and/or equivalent professional experience in health care.
• You possess a minimum of 3 years' experience in clinical study execution with a thorough understanding of Good Clinical Practice (GCP), alternatively senior professional knowledge, with extensive functional, commercial and/or technical knowledge in laboratory diagnostics.
• You plan your own work according to targets agreed to by integrating resources in a project-driven, fast-paced environment. You provide functional advice and guidance to colleagues and external partners. You take accountability, build relationships, and act with integrity.
• You possess solid professional judgment and problem-solving competence to improve existing processes and approaches.
• You provide specialized guidance or train support and/or professional staff.
• You possess leadership and role model qualities and aspire to manage and develop others. You desire to work with industry leaders, key opinion leaders and subject matter experts.
• You are willing to travel up to 20%.

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 Careers - Siemens Healthineers USA (siemens-healthineers.com)

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