Clinical Studies Engineer II

Summary

BIOTRONIK is a manufacturer of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology, and vascular intervention. The Clinical Studies Engineer II will plan, execute, manage, and report clinical investigations involving medical device technologies while supporting investigative sites, clinical data analysis, regulatory submissions, and cross-functional clinical and technical activities.

Responsibilities

• Participate in all phases of clinical investigations, including study design, initiation, enrollment, study execution, data analysis, and clinical report writing
• Lead the development and revision of clinical study protocols
• Design case report forms (CRFs) to support accurate, comprehensive data collection and analysis in accordance with study protocols
• Develop study documents, training materials, and other resources supporting clinical protocols, study procedures, and CRF completion
• Provide day-to-day study management and support to investigative sites
• Serve as a clinical and technical resource for site coordinators, investigators, field clinical personnel, sales representatives, and other internal stakeholders
• Train investigative sites and BIOTRONIK personnel on clinical protocols, investigational devices, study procedures, and data collection requirements
• Support sites and field personnel in collecting complete, accurate, timely, and compliant clinical data
• Review and/or monitor case report forms, source documents, and other study records in accordance with BIOTRONIK procedures and applicable regulatory requirements
• Collaborate with study teams, field personnel, and investigative sites to resolve data discrepancies, compliance concerns, and regulatory issues
• Identify and report significant protocol compliance issues and support appropriate resolution
• Develop solutions to logistical and operational challenges that arise during study execution and communicate recommendations to appropriate stakeholders
• Build and maintain strong professional relationships with investigators and investigative sites
• Partner with Clinical Data Operations to clean, organize, summarize, and analyze complex clinical data
• Generate clinical reports and contribute to scientific publications
• Support preparation of clinical content for FDA submissions
• Participate in FDA meetings as a clinical representative when needed, including presenting and explaining device features, clinical study design, and study results
• Develop an in-depth understanding of BIOTRONIK products and associated clinical procedures, which may include technologies within cardiac rhythm management, vascular intervention, and/or spinal cord stimulation
• Develop training and clinical study support materials for investigational or study devices and procedures
• Collaborate with Advanced Product Support and other internal teams to address technical and study-related questions
• Attend device implants and/or follow-up procedures as needed to remain current on devices, clinical utilization, and patient care
• Provide clinical and technical feedback to Engineering and Research & Development teams as needed
• Contribute clinical expertise to new project planning and development initiatives
• Support the training and mentoring of newly hired Clinical Studies Engineers
• Provide support to other clinical studies and projects as business needs require

Skills

• * Bachelor's degree in a health profession, science, engineering, or related field with a strong technical and clinical background
• * Working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other regulations and standards governing clinical research
• * Demonstrated ability to develop expertise in relevant therapeutic areas and quickly learn and integrate knowledge of new technologies and clinical applications
• * Strong written and verbal communication, presentation, and interpersonal skills
• * Excellent organizational skills and attention to detail
• * Ability to manage multiple priorities and work effectively both independently and as part of a cross-functional team
• * Strong computer skills and ability to work effectively with clinical study data and documentation
• More than three years of successful experience as a Clinical Studies Engineer I within BIOTRONIK's Clinical Studies department, along with completion of Clinical Studies Certification in a product area of primary study support
• Comparable clinical studies experience with another organization in a similar position or relevant field
• * Travel is generally limited to less than two weeks per year for clinical procedures, investigative site training, and meetings. Depending on study needs and the phase of a clinical investigation, travel may periodically increase to up to 25%
• * The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers
• * Must be able to work a minimum of 40 hours / week
• * Must be able to travel
• * Master's degree in a health profession, science, engineering, or related discipline
• * Experience in a clinical setting, biostatistics, IDE clinical studies, and/or medical device support
• * Previous experience supporting medical device clinical investigations

Qualifications

Must Haves

• * Bachelor's degree in a health profession, science, engineering, or related field with a strong technical and clinical background
• * Working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other regulations and standards governing clinical research
• * Demonstrated ability to develop expertise in relevant therapeutic areas and quickly learn and integrate knowledge of new technologies and clinical applications
• * Strong written and verbal communication, presentation, and interpersonal skills
• * Excellent organizational skills and attention to detail
• * Ability to manage multiple priorities and work effectively both independently and as part of a cross-functional team
• * Strong computer skills and ability to work effectively with clinical study data and documentation
• More than three years of successful experience as a Clinical Studies Engineer I within BIOTRONIK's Clinical Studies department, along with completion of Clinical Studies Certification in a product area of primary study support
• Comparable clinical studies experience with another organization in a similar position or relevant field
• * Travel is generally limited to less than two weeks per year for clinical procedures, investigative site training, and meetings. Depending on study needs and the phase of a clinical investigation, travel may periodically increase to up to 25%
• * The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers
• * Must be able to work a minimum of 40 hours / week
• * Must be able to travel

Nice to Haves

• * Master's degree in a health profession, science, engineering, or related discipline
• * Experience in a clinical setting, biostatistics, IDE clinical studies, and/or medical device support
• * Previous experience supporting medical device clinical investigations

Benefits

• Work location is hybrid out of our Lake Oswego, Oregon campus -or- remote within the United States based on skill set and qualifications.