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Posted June 30th, 2008
BIOTRONIK is one of the world's leading manufacturers of products and services for cardiac rhythm management and vascular intervention and is represented in over 100 countries worldwide. We now have an opening for a Clinical Engineer - Vascular Intervention located in beautiful Pacific NW near Portland, OR. (Relocation help will be provided).
POSITION SUMMARY:
Responsibilities will include the management of all aspects of the IDE Clinical Study on our peripheral stent, including protocol development, assist regulatory with IDE and PMA submission, train clinical studies department and field personnel as well as investigational site personnel on the device and the study, participate in study implants and follow-ups, data analysis and clinical report writing. The ability to make recommendations necessary to promote medical acceptance of the peripheral stent and be the internal resource and expert on the device are a required asset.
RESPONSIBILITIES:
Product Knowledge:
Develop training and other support materials for investigational and study devices and procedures Train investigational centers, Field Clinical Engineers, Field Clinical Specialists, Sales Representatives, and other BIOTRONIK personnel on investigational and study devices
Interface with Technical Services and Engineering in order to obtain answers to technical questions Attend investigational device implants and follow-ups as a technical and clinical resource for the staff at the investigational center, Field Clinical Engineers, Field Clinical Specialists, and Sales Representatives
Provide clinical and technical feedback to Engineering development groups
Provide input for new project planning
Attend FDA meetings as the clinical representative in order to present and explain new device features
Clinical Studies
Serve as a resource to site coordinators, investigators, sales representatives, and other staff members regarding investigational and study devices and protocols
Lead the protocol design development process
Design case report forms for sound and thorough data collection to support the data analysis in accordance with the protocol
Develop training and other support materials for clinical protocols, study procedures and CRF completion and review
Train site and field personnel on data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements
Assist in the development and implementation of a study-specific database for clinical studies
Assist site coordinators, investigators, field clinical staff, and sales representatives in collecting data in a timely manner that meets the protocol requirements
Review patient study records submitted to BIOTRONIK including case report forms, source-documents, consent forms, and other materials
Assist the CRA with interfacing with site staff to resolve data discrepancies, compliance, and/or regulatory issues
Assist the CRA group with on-site and/or in-house monitoring, when applicable, in accordance with BIOTRONIK Standard Operating Procedures, to ensure accurate data collection and adherence to FDA and protocol.
Organize, summarize, and analyze complex clinical data for clinical report writing and, when applicable, for submissions to the FDA
Generate clinical reports and publications
Assist in writing the clinical portion of FDA submissions
Provide support and assistance to team members in completing other trials when necessary, for example, participation in Pacemaker, ICD and CRT trials will be expected
Perform other clinical duties as requested
Support BIOTRONIK in maintaining current and developing new professional relationships with investigators and investigative sites
Develop solutions for logistical and operational issues that arise during study execution, and communicate these in a timely fashion to management, field and site personnel
Identify and report serious protocol compliance issues
Certifications:
Upon participation in Pacemaker, ICD and CRT clinical studies, obtaining Brady, Tachy and CRT certification will be required
REQUIREMENTS:
More than 3 years experience in a clinical scientific setting with clinical studies in the field of vascular intervention, preferably peripheral or cardiac stents
Bachelor's degree in health profession, science, or engineering field with a strong technical and clinical background. Masters degree preferred.
Previous experience in the medical device industry including interaction with physicians during the implantation, follow-up, and trouble-shooting of implantable medical devices, preferably cardiovascular devices is desired
Knowledge of project management tools and practices
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
Demonstrate aptitude in and knowledge of relevant therapeutic areas and ability to learn and integrate new/different therapeutic areas
Ability to work independently and as a part of a team
Additional experience in a clinical settings, biostatistics, IDE clinical studies, or medical device sales is beneficial
Excellent communication, presentation, interpersonal, and computer skills
Database management experience
Excellent organizational skills and attention to detail
TRAVEL REQUIREMENTS:
Travel is required up to 25% of the time in order to support clinical procedures, training programs, and FDA meetings
For consideration please send your resume to:careers@biotronik.com
For more information on BIOTRONIK, Inc. please visit our website at www.biotronik.com