- Conduct training of both BIOTRONIK personnel ( Field Clinical Specialists and Sales Representatives) and external customers ( Clinical Research Coordinators and Investigators at study sites) on clinical devices and applicable clinical studies
- Assist the Clinical Studies project teams and the Clinical Sites with the successful and timely conduct of all phases of Clinical Studies including study initiation, site training, assistance with data collection, as well as assist Clinical Studies project team personnel with data and query resolutions
- Contribute to ongoing studies by assisting with the following tasks: ensure study and site compliance with applicable federal regulations and BIOTRONIK policies and procedures; provide study site support; interface with Clinical Research Coordinators, Investigators, Clinical Studies Personnel, and other company representatives
- Independently train Investigational Centers, Field Clinical Specialists, Sales Representatives, and other BIOTRONIK personnel on protocol required data collection from investigational and study devices
- Interface with Advance Product Support and Engineering in order to obtain answers to technical questions
- Attend study related market released product device implants and follow-ups to increase knowledge of BIOTRONIK products
- Attend investigational device implants and follow-ups to assist as a technical and clinical resource for the staff at the Investigational Center
- Answer questions from Clinical Research Coordinators, Investigators, Sales Personnel, and other staff members regarding investigational and market released study devices and study protocols, including Home Monitoring devices and HMSC
- Train and assist Clinical Sites and Field Personnel on data collection methods to ensure timely collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements
- Assist Clinical Research Coordinators, Investigators, Clinical Studies Personnel, and Sales Personnel in collecting data in a timely manner that meets protocol requirements
- Assist the Clinical Studies project teams with site identification and qualification, on-site and/or remote monitoring and eCRF review, when applicable, in accordance with BIOTRONIK Standard Operating Procedures, to ensure accurate data collection and adherence to FDA and protocol requirements
- Assist the Clinical Studies project teams in completing other tasks when necessary
- Responsible for maintaining current relationships and developing new professional relationships with Investigators and study sites
- Identify logistical and operational issues that arise during study execution, and communicate these in a timely fashion to management
- Identify and report serious protocol compliance issues to management and the study team
- Bachelor's degree in health profession, science, or engineering field with a strong technical and clinical background. Master's Degree preferred
- 3+ years Clinical Studies or relevant field experience
- Demonstrate an ability to learn relevant therapeutic areas and ability to integrate new/different therapeutic areas (, cardiac EP/Cath lab experience, IBHRE Certification, industry conducted training program)
- Ability to work independently and as a part of a team
- Excellent communication, presentation, interpersonal, and computer skills
- Excellent organizational skills and attention to detail
- CRM, VI, and SCS certification according to the Clinical Studies Certification Requirements and/or internal requirements
- West Coast, preferably California
- Travel is required 50-75% of all working days and candidate is able to work both on-site and remotely to support and manage sites
- This is a full-time position. Standard days of work are Monday through Friday. Evening and weekend work may be required as job duties demand.
- While performing the duties of this job, the employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
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Field Clinical Studies Engineer II - Lake Oswego, United States - BIOTRONIK
1 week ago
Description
Field Clinical Studies Engineer II
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
BIOTRONIK is seeking exceptional talent to join our world-class Clinical Studies team. Candidates with strong communication and relationship building skills, coupled with technical acumen and the ability to work both independently and as a part of a team. Be a part of delivering new technology to help improve and save patients' lives. Candidates key functional responsibilities will include:
Possess an in-depth knowledge of BIOTRONIK products and clinical procedures including, but not limited to, devices undergoing IDE clinical studies in cardiac rhythm management, vascular intervention, and/or spinal cord stimulation
YOUR RESPONSIBILITIES:
Product Knowledge
Clinical Studies
YOUR PROFILE:
CERTIFICATIONS:
WORK LOCATION:
TRAVEL:
POSITION TYPE AND EXPECTED HOURS OF WORK:
PHYSICAL REQUIREMENTS:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
