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BIOTRONIK · 1 month ago

Field Clinical Studies Engineer II

Lake Oswego, OR

Contract

Hybrid

Mid Level

3+ years exp

BIOTRONIK is a leading manufacturer of cardio- and endovascular implants and catheters, seeking exceptional talent for their Clinical Studies team. The Field Clinical Studies Engineer II will be responsible for training personnel, assisting with clinical studies, and ensuring compliance with regulations while supporting clinical sites.

BiotechnologyHealth CareMedical

Responsibilities

Conduct training of both BIOTRONIK personnel (e.g. Field Clinical Specialists and Sales Representatives) and external customers (e.g. 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

Qualification

Clinical Studies experienceCRM certificationTechnical training skillsInterpersonal skillsOrganizational skillsCommunication skillsPresentation skillsAttention to detailTeamworkIndependent work

Required

Bachelor's degree in health profession, science, or engineering field with a strong technical and clinical background

3+ years Clinical Studies or relevant field experience

Demonstrate an ability to learn relevant therapeutic areas and ability to integrate new/different therapeutic areas (e.g., cardiac EP/Cath lab experience)

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

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