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Clinical Affairs Scientist

Job Description

The Ultrasound Division of Siemens Healthineers is looking for a Clinical Scientist for our Mountain View, CA or Issaquah, WA location.

The Clinical Scientist is a member of the Clinical Affairs team. He/She will collaborate with a cross functional project team to conduct clinical evaluation, define post market clinical follow up (PMCF) activities, participate in assessment of clinical benefit-risk profile and support post market surveillance (PMS) activities.  
This position is responsible for planning and coordinating the development managing clinical affairs projects, acting as global PI for internal studies.

Responsibilities:
  • Responsible for the overseeing of clinical studies including analysis of potential patient recruitment, organizing study related documents (protocols, case report forms, informed consents, monitoring plan), managing IRB/EC submissions including New Protocol, Continuing Review Report, Amendments, promptly reportable incidents, Protocol Deviations and/or Adverse Event with follow thorough to ensure successful outcome.
  • Author and review preclinical and clinical documents including protocols and amendments, IRB applications, informed consent forms, statistical analysis plans (SAP), and clinical monitoring plans (CMP), annual reports and preclinical and clinical study reports
  • Conduct Systematic literature reviews and Meta-analysis to provide clinical evidence in evaluation of safety and performance of our product portfolio, critically appraise scientific literature and write Literature search Reports to assist Clinical Evaluation as well as development of clinical strategies and clinical investigation protocols.
  • Participate in data review, analysis, and interpretation to provide input to   clinical study evaluation reports and /or support quality/regulatory decisions
  • Assist in the development and review of electronic data capture strategies (EDC with eCRFs) and assist in implementation and maintenance of clinical study databases
  • Provide overall direction and guidance to the cross-functional project team on clinical evaluation, PMCF and clinical development activities. 
  • Plan, execute, and finalize deliverables for CE marking products including but not limited to clinical evaluation plan (CEP), CER, PMCF plan, PMCF Report, Summary of safety and clinical performance etc. within the triple constraints of delivering on time, within budget and scope objectives.
  • Identify, effectively communicate and resolve project issue, risks and develop mitigation plans.
  • Effectively communicate project status to project stakeholders and top management.
  • Support of FDA/TUV communication as well as management of Clinical Research Organizations/Outsourcing vendors and Key Opinion Leaders.
  • Foster early involvement of Product Manager, Risk managers and post-market managers into the CE marking deliverables for each project.
  • Represent development team during internal as well as external audits by TUV and FDA
  • Proactively work to improve systems and procedures and act as a cross-functional liaison with legal, quality, product management and clinical teams. Develop/maintain SOPs, processes, and templates to strategically standardize clinical tasks and improve efficiency.
Education and Knowledge:
  • Advanced degree in sonography/scientific/bioengineering/Health Sciences or related field (M.S., Ph.D, M.D., or PharmD)   with 2+ years of experience in clinical and/or regulatory affairs in academic or industry settings or BS/BA with 7 + years related experience; preferably in a highly regulated medical solutions industry.
  • Demonstrated strong leadership and execution of reaching critical program goals/milestones while meeting quality, performance, schedule, and budget constraints.
  • Demonstrated problem solving capability and results orientation.
  • Experience in research methodology (clinical investigation design, biostatistics), scientific literature review (PUBMED, EMBASE, MEDLINE etc.) and medical writing.
  • Expertise in systematic literature searches for safety, performance and state of the art, literature review and appraisal of clinical data.
  • Experience of FDA (21 CFR 212, 21 CFR 820 etc.), EU (MDR, MEDDEV 2.7/1), ISO 14155/GCP and   other regulatory standards.
  • Experience in marketing / clinical claims management and mapping clinical evidence to marketing/clinical claims.
  • Strong critical/analytical thinking and problem-solving skills.
  • Strategic planner, self-starter, collaborative team player and clear thinker.
  • Excellent interpersonal, written / verbal communication and presentation skills.
Preferred:
  • Ultrasound and/or Imaging catheter experience preferred.
  • Experience with regulatory submissions for EU Class III devices.
  • Advanced degree (MD, PharmD, PhD etc.) and/or experience in radiology, cardiology or medical imaging.
  • In-depth understanding of EU MDR, Risk Management and imaging.
  • Collaborative team product development processes / requirements.
  • Experience in clinical trials and experience with Institutional Review Boards (IRB)/Ethics Committee (EC).
  • Regulatory Affairs experience for EU CE Marking and supporting technical documentation.

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.

(Note: Accommodations may be requested for certain medical or religious reasons)

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

*LI-WC1

Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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