BIOTRONIK is looking to add an experienced Clinical Studies Engineer to our Clinical Studies team. The Senior Clinical Studies Engineer is responsible for utilizing an in-depth knowledge of BIOTRONIK products and clinical procedures to support clinical trial design, development, execution, and outcomes reporting for sponsored projects. In this role, you would be responsible for building key relationships with global BIOTRONIK teams and external partners, including physicians and study center staff, as well as support communication with FDA.
- Contribute to all phases of clinical studies by developing study design, writing protocol, determining data collection requirements and methods, creating study and training documents, monitoring device and procedure-related case report forms, and preparing clinical reports
- Collaborate with statistical programming team to clean, organize, summarize, and analyze complex clinical data for clinical report writing and, when applicable, for submissions to the FDA
- Support clinical physician consultants, including key opinion leaders in the respective field, to develop abstracts and manuscripts
- Provide day-to-day study management and site support, plus interfaces with site coordinators, investigators, field clinical staff, and other company representatives
- Assemble clinical and technical feedback from various sources, including Advance Product Support, Engineering or Research and Development groups, to support informed decision making
- Keep current with changes in cardiac devices, device utilization, and patient care by engaging in learning opportunities, including review of relevant literature, attending trainings or conferences, and implant or study site visits
- Conduct research and provide input for new project planning
- Assist with development of FDA communications, including pre-submissions and PMA applications, and attend FDA meetings as a clinical representative in order to present and explain new device features, study design, or study results
- Provide leadership for Clinical Studies Engineers I and II in performing day to day responsibilities for clinical studies
- Minimum of 6 years of experience in comparable position
- Bachelor’s degree in health profession, science, or engineering field with a strong technical and clinical background. Master’s degree preferred.
- Excellent communication, presentation, interpersonal, and computer skills
- Strong analytical skills (problem solving and critical thinking, organizational skills, and attention to detail
- Ability to work independently and as a part of a team
- Working knowledge and understanding of FDA, ICH, GCP regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research
- Demonstrated aptitude in and knowledge of relevant therapeutic areas is desired
- Travel to support or observe clinical procedures, study center training, and meetings is typically limited (< 2 weeks per year) but may be up to 25% at times depending on study needs and/or study phase
To apply for this job please visit career012.successfactors.eu.