INSIGHTEC’s technology transforms the world of medicine by offering an innovative, ground-breaking non-invasive therapy platform that reduces the need for invasive surgery – COME ONBOARD
At INSIGHTEC, we value innovation, precision and operational efficiency. We are dreamers with unlimited amount of dreams, as we believe there is a chance to do something differently in almost everything that you touch. If you are passionate and share INSIGHTEC’s vision of transforming medicine as we know it, join our world class team to participate in the development of this innovative therapeutic technology.
US (West cost)
Service and Support Engineer
- Responsible for supporting INSIGHTEC’s systems at clinical sites throughout N. America
- System troubleshooting and diagnosis of source of failures
- Preventive maintenance and repairs
- Failure, maintenance and service reporting in ERP system
- Perform system installations at new sites in the US
- 3-5 years’ experience in field service for multi-disciplinary systems
- Ability and drive for learning and work on new technology
- Organized, structured, capable working independently
- Good oral and written communication skills
- “Hands on” character
- Good interpersonal skills
- Good mechanical capabilities
- An ability to solve Hardware and Software problems dealing with variety of multivariable situations
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule
- Travel 60 – 80%, mostly US. Some international travel for training purposes
- Working hours second and third shift
Desirable Additional Skills or Experience
- B.Sc. in Electrical Engineering
Sales Executive – North-West Zone, US
Preferred Location: WA, OR, MT, ID, WY, ND, SD, NE, MN, IA
Maximize orders, sales, and drive market penetration in assigned territory. Identify and focus on priority academic and private/community center accounts and represent INSIGHTEC solutions and vision to customers in the geography with credibility to drive visibility, awareness and market proliferation. Collaborate with our partners in GE & Siemens, INSIGHTEC clinical, service to drive market entry planning and adoption. Primary focus is to drive sales of INSIGHTEC’s neuro platform.
Main objectives and activities:
- Sell INSIGHTEC products in accordance with the company policies for your area.
- Set meetings and organize in presentations, in full compliance with local regulations, to appropriate customer audience – Neurosurgeons, hospital CxO, department chair, neurology, urology & radiology
- Build the appropriate Economical / business model information, including reimbursement status, downstream revenue, sponsor research programs and any business financial data the required for customer decision
- Work with VP Americas and coordinate with the GEHC and/or Siemens Sales force as needed to process and close sales deals
- Provide ongoing updated orders and sales forecast reports
- Generate, record and maintain customer profiles, including keeping track of key critical & technical decision makers for assigned accounts.
- Stay current with healthcare market dynamics in USA and Canada and be able to speak to this with authority at all levels from C-suite to physicians, administrators & supply chain
Bachelor’s degree in Science or equivalent is a must, MBA is preferred
Minimum 7 years' experience in selling disruptive medical device technology to neurosurgeons, neurologists, community hospitals, imaging centers and academic hospitals
- 75% travel required and mandatory
Critical skills & abilities:
Hunger to win and passion to solve customer problems & drive customer outcomes
Problem solving - Execute to win without a perfect organization for back operations
Know how to navigate and integrate into the planning and capital/service line decision making in complex national hospital entities, government / VA system as well as IDNs
Critical thinking abilities – how to target accounts, get client interested, couch clinical value in economic interests for client
Technical competency and clinical depth while not losing sight of commercial intensity and sales results
Be a Trail blazer – know how to pick, position and sell to “headpin” accounts to enter into the account and leverage this to drive incremental sales in other sites within the account
- Be excited to work in a new space that will revolutionize non-invasive surgical procedures & share this enthusiasm with potential customers
- Strong relations with and Deep understanding of Neuro surgeons, Radiation Oncologists, Interventional Radiologists, cancer service line administrators
Requisite project management skills to close a deal
Regulatory Affairs Specialist-Americas
- Preparation and maintenance of regulatory submissions and registrations of InSightec devices in the US (FDA) and Canada (Health Canada)
- Preparation and submittal of periodic reports for InSightec’s Class III devices in the US
- Preparation and maintenance annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses
- Review of customer complaints to determine regulatory reportability requirements; In collaboration with the RA Director, preparation/submittal of regulatory reportable events
- Actively participate in evaluation of changes to the InSightec’s QMS documents and device design/process for impact on pending or existing registrations
- Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- In collaboration with the RA Director, advise project teams on premarket regulatory requirements, labeling requirements and/or clinical study compliance issues
- Monitor and advise the RA Director of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategies are in alignment with company objectives
- Interpretation of regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Participate in compliance activities that relate to the department and the company, when needed
- Work closely with various teams (i.e. Regulatory Affairs, R&D, Quality, Manufacturing and Marketing) located at the InSightec’s headquarters in Israel and ROW
- Perform other duties as required
Required Skills or Ability to:
- Apply business and RA ethical standards
- Multitask and manage multiple projects to meet deadlines
- Perform due diligence; Assess and interpret regulatory requirements and their impact
- Work with cross-functional teams (located in the US and Israel)
- Communicate effectively verbally and in writing (English) as well as with team members from various cultural backgrounds
- Write, review and prepare complex documents (English)
- Think analytically and critically
- Proficient with Microsoft Office
- B.S. or B.A. degree in scientific or technical discipline. Advanced degree preferred.
- A minimum of 8 years of working in an FDA regulated environment,
- A minimum of 5 years of Regulatory Affairs experience with the US FDA Class III and/or Class II medical devices
- Must have experience with regulatory registrations and submissions in markets such as US and Canada
- RAPS RAC (US) preferred
- Ability to travel both domestically and internationally is required
Clinical Research Associate
The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.
The CRA has broad exposure to clinical research tasks as a combination of in-house and field work. The CRA works closely with the VP Global Regulatory Affairs and CRO, Project Manager(s) and Clinical Project Team to support various aspects of a Clinical Trial and related regulatory activities.
Field CRA Responsibilities
- Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports.
- Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
- Review all source records for patient safety and ensure complete documentation of all subject safety events.
- Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
- Ensure compliance with protocol and overall clinical objectives.
- Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
- Ensure investigator involvement in the study and IRB/EC oversight.
- Follow through after visit to outstanding requests/needs are fulfilled.
- Raise issues of significance to the appropriate level for resolution.
- Able to help site navigate informed consent issues and support IRB approval process. Compilation of Regulatory Submissions
- Assist in organizing documentation for regulatory submission, including IDE and PMA FDA submission
- Create electronic copies of submitted documents
- File all regulatory correspondence in the RMF
- Responsible for accurate and timely maintenance of both electronic and paper files
Set up and maintenance of Regulatory Master File
- Organize site study binders
- Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation, and assuring consistency between RMF and site files.
- Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s).
- Responsible for accurate and timely oversight and maintenance of RMF.
- Demonstrated expertise in understanding and managing clinical study documentation.
- Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable SOPs.
Required Knowledge and Skills
- Minimum of a 4-year Bachelor’s degree, preferably in life sciences field and basic familiarity with medical terminology
- Basic computer skills with proficiency in Microsoft Word and Excel required; Powerpoint and Database experience desirable
- Ability to foster relationships with clinical sites and colleagues
- Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
- Able to work independently with excellent time management skills
- Excellent work ethic with desire to be a valuable contributing team member
At least 2-3 years relevant industry experience in clinical research environment
Approximately 50% travel that will vary over time, including limited international travel to Canada/Europe (able to obtain passport).
Clinical Project Manager
Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (ICHGCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the Regulatory Agency(ies) governing the study, and any other applicable guidelines and regulations.
Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve expectations of quality, timelines and budget, and study conduct.
Manage successful Clinical Research and Clinical Trials submissions (as needed) to governing Regulatory Agency(ies) in full compliance with local regulatory laws
Builds and sustains extensive global networks across multiple functions at study team level.
Develop and share best practices to accelerate project timelines
Develop professional relationships with investigational sites and key opinion leaders involved in assigned study(ies) to ensure appropriate stakeholder engagement and support.
Manage site relationships and provide timely input to ensure that trials are executed according to agreed project plan.
Manage internal company relationships and maintain open communication to successfully meet projected trial timelines, trial execution and completion.
Manage study team performance and CRO subcontractors to ensure adherence to agreed deliverables within timelines.
When applicable, manage relationships with the governing Regulatory Agency, in collaboration with the local regulatory agencies. Ensure full compliance with global/local regulations.
Hands-on management of assigned clinical trials to ensure that timing of all major trial milestones meets the plan. Specifically, track and evaluate trial milestones and monitor overall operational performance metrics through life of the trial. Identifies issues early and proposes and tracks solutions. Elevates critical issues to management and, whenever possible, resolves issues in a professional manner in accordance with company policies. Coordinates updates, including presentations/communications, on assigned trials to management. Coordinates protocol amendments and data base changes within the study team and documents all changes for the regulatory files. Leads the change initiative with the sites in an orderly and efficient planned process.
Works with internal CRO to ensure trial risk assessment is complete, and that mitigation and contingency measures are prepared and implemented. Actively assesses potential risks to trial and implements mitigation plans, as needed.
Develops key site relationships with the site personnel and serves as the key point of contact for operational and process related issues and inquiries for assigned trial(s).
Takes specific responsibility to manage quality of clinical trial initiation, execution, recruitment efforts, coordination and oversight of monitoring activities, direct database management, and data analysis, including and not limited to successful data base lock (DBL) and reporting; coordination of Data Safety Monitoring Board, as needed.
Responsible for written regulatory/clinical communications for assigned trials, including, but not limited to protocol and CRF development, responds to regulatory deficiency letters, develops annual reports with safety reporting, SAE/UADE reports, final Clinical Study Reports, CE Mark reports, and other internal reports as needed.
Liaise with vendors and internal stakeholders to ensure timely data base lock is achieved.
Processes & Procedures
Manage appropriate implementation, conduct, tracking and reporting of assigned trial(s) including quality review of trial information within internal clinical trial management practices used to support and manage assigned responsibilities
Identifies and assists with opportunities for process development, improvement and implementation of policies, procedures and processes related to Good Clinical Practice, SOPs, and assigned clinical trial activities.
Skills and Qualifications
Bachelor’s degree required in medical/healthcare-related science field. Advanced degree preferred.
6-8 years of regulatory / global clinical trial experience (preferably in medical device industry), with at least 2 to 3 years of executing global feasibility, pivotal and post-approval trials.
Preferably, ~ 5 years of experience with PMA Class III device process. Experience with global regulatory processes are welcomed. Experience with various international clinical trials regulations also desirable.
Demonstrates current working knowledge of all phases of clinical trial development from concept through final Clinical Study Report and knowledge of operational and regulatory processes involved with clinical trials. Professional certification for clinical trials management is welcomed.
Demonstrates strong database management skills, including and not limited to Oracle Clinical and Medi-Data to Excel data import /export management and descriptive data analysis
Demonstrates technical competence and experience in design, implementation, tracking and completion of global clinical trials to commercialization with highest standards of quality and GCP and the ability to deliver trials on time and within budget.
Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources to achieve successful results.
Ability to collaborate, align and manage diverse, global cross-functional matrix teams.
Able and willing to travel as needed, including international travel
Professional in English is a MUST.
In-depth knowledge of global clinical trial processes and regulations (US-FDA, ISO, Health Canada-ITA/CTA, and familiarity with Japan, China and South Korea).
Understanding of principles, implementation and maintenance of regulations.
Knowledge of global trial planning, management principles, and business processes.
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
Clinical Electronic Database Specialist
Responsible for leading and/or supporting database build activities for EDC clinical studies and related setup tasks including eCRF/study design, edit check programming, randomization, coding setups, external data import setups, listings/report development as needed following the appropriate company SOPs.
Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (eCRF)s, database creation, coding setup, randomization, edit check procedures, import, export setup and processing including SAS and/or Excel datasets, listings, reporting requirements.
Assists in User Access Management for Data Management/Clinical systems as required.
Develop & maintain reporting & analytics
Proactively provides process improvement feedback to Management and provide input in SOP updates/development.
Participate in Internal/External audits as required.
Assist in developing programming related timelines.
Provides technical support on Data Management/Clinical systems including CDMS (EDC) packages such as Oracle, Rave, reporting tools, custom functions, etc.
Proactively monitors internally and externally hosted applications for performance and/or system errors.
Assists in addressing external application vendor issues, integrations, and implementations
Assists in managing workload by reviewing status updates and study metrics.
Provides relevant training, guidance, and support to peers and other department members as required
Collaborates with clients, peers, project teams and/or requestors to clarify and finalize specifications and uses technical skills to meet evolving project needs.
Provides support to senior and manager level clinical database programmers as needed.
Provides Support for Implementation of upgrades and new modules of remotely hosted vendors, acquiring all documentation and storing in the relevant areas.
Maintains and continues to gain a broad overall knowledge in the field of clinical programming and clinical data management.
Performs other work-related duties as assigned.
Must be willing to travel, around 20% of their time.
Ensure that all standards are met and maintained as per SOPs, ICH and GCP guidelines.
Experience with at least Oracle Clinical programming hands-on experience, TSQL, Databases (Oracle, SQL), at least one programming/Scripting language (C#, VB etc.).
Ability to lead activities performed by technical developers and/or data managers;
Ability to work effectively and comfortably with multidisciplinary teams of researchers, IT specialists and support staff;
Strong problem-solving skills and a willingness to be flexible and learn new concepts and technologies on the job;
Excellent oral and written communication skills in English;
Preferred Experience and Skills
Excellent verbal and written communication skills as well as interpersonal skills are required.
Has expertise and knowledge of relational database design
Familiarity/knowledge of FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems are desirable
Experience developing applications (web or otherwise) in the context of research studies; Familiarity with an Electronic Data Capture (EDC) system such as Oracle Clinical, Medidata RAVE®, or other EDC systems a plus;
Working knowledge of clinical and epidemiological research and implementation of data collection systems.