Clinical Research Associate

Position Summary:

The Clinical Research Associate (US) will support regional conduct of clinical research within clinical research centers that are actively participating in Nuvaira clinical trials. The Clinical Research Associate (CRA) will act as the site manager for assigned clinical centers and will be responsible for developing positive relationships by providing clinical protocol training and support, study monitoring, clinical investigation awareness, recruitment assistance and continuing education for our emerging medical device. The CRA will also be responsible for communicating internally any market dynamics, study issues or potential improvements, study activities/compliance, adverse event information and study enrollment strategies. The CRA will work with members of the clinical study team(s) and assist with clinical vendor management and study long-term follow-up logistics as appropriate.

Responsibilities:

  • Act as the primary point of contact with assigned clinical study sites;
  • Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
  • Ensure clinical study site compliance according to GCPs, ICH and FDA regulations;
  • Schedule, conduct and document Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits;
  • Provide and document initial and ongoing study training (eg. protocol, EDC, etc.) to study site personnel;
  • Ensure the protection of study subjects by verifying that the informed consent procedure and study protocol testing and procedures are performed appropriately and in alignment with the study protocol;
  • Ensure the integrity of the clinical data submitted on eCRFs or other data collection tools by verifying against source documentation at the clinical study site;
  • Ensure appropriate record-keeping at the clinical site, as well as the collection and submission of essential study documents to the study sponsor;
  • Ensure appropriate investigational device storage and tracking at the clinical site;
  • Independently identify and follow up on adverse events and other safety issues related to the clinical study, and ensure timely communication of serious adverse events to the Clinical Study Manager;
  • Provide relevant, timely study subject updates to the Clinical Study Manager (eg. upcoming treatment dates, subject withdrawals, etc.);
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
  • Collaborate with clinical study site and sponsor to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
  • Work closely with clinical product training and proctoring teams;
  • Assist in patient recruitment activities;
  • Assist clinical study sites with audit preparedness;
  • Assist with the development of study-related documents as requested;
  • Prepare accurate and timely study visit reports as required by the study monitoring plan;
  • Manage travel and expenses;
  • Work independently and under general supervision.

Qualifications:

  • Bachelor’s degree (or higher) in nursing, health sciences or related field
  • Minimum of two years of CRA experience with at least one year of clinical site monitoring;
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
  • Respiratory disease trial experience preferred;
  • Medical device trial experience preferred;
  • Strong oral and written communication skills;
  • Proven organizational skills and the ability to manage multiple priorities
  • Ability to travel approximately 50% with extensive travel during peak periods (up to 75%)
  • Ability to manage personal expenses
  • Strong computer skills

 

Physical Job 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.  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, and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Clinical Specialist – Europe

Position Summary:

The Clinical Specialist is the expert on all aspects of Nuvaira’s products and procedures.  S/he will be responsible for contributing to the development of world-class physician training programs, and providing training and on-site proctoring of physicians and users of Nuvaira products during clinical trials and commercial activity, supporting physicians in French- and German-speaking parts of Europe.  Working as part of a small team, the clinical specialist will train physician users and their staff, guide treating centers to building procedural competency, and proactively organize and communicate feedback to Nuvaira to inform our product enhancement and continuous improvement of our training programs.  Additionally, the Clinical Specialist may work cross-functionally on market development projects such as  investigator-initiated studies and identification and development of centers-of-excellence and selective site expansion.

Responsibilities:

  • Develop recognized expertise with all aspects of the dNerva® targeted lung denervation system
  • Develop expert-level skill in proctoring procedures, including guiding and advising physicians and HCP teams in best-practices to ensure optimal procedures and outcomes
  • As a Voice of Customer representative, develop trusted relationships in assigned accounts to synthesize and relay physician and site feedback to Nuvaira
  • Embrace and maintain compliance with all company policies and procedures
  • Professionally represent the company at internal and external meetings
  • Participate in internal product development/testing/evaluation meetings and testing
  • Engage and support the training of Healthcare Professionals (“HCPs”), KOLs, existing and potential customers, and other clinical and non-clinical organizations and groups

Qualifications:

  • Bachelor’s degree or equivalent preferred
  • Minimum 3 – 4 years medical device training experience required
  • Experience providing hands-on training for HCPs in the field of pulmonology (bronchoscopy) and familiarity with standard endoscopy equipment preferred
  • Clinical experience and cultural fluency in France and Germany
  • Ability to work independently (non-headquarters based position)
  • Willing to travel nationally/internationally up to 75% of the time during clinically active periods
  • Proven organizational and interpersonal skills and the ability to manage multiple priorities
  • Strong oral and written communication skills including English (competence)
  • Ability to interpret/use/present scientific literature and clinical study results
  • Computer skills including proficiency in Microsoft office suite

 

Physical Job 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.  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, and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Market Development Manager – DACH

Position Summary:

This individual will lead Nuvaira’s strategic market development in the DACH region (defined territory (half) of Germany, and Austria and Switzerland).   This individual will be responsible for physician training, education, site management and developing regional and local referral networks as part of our strategic development initiative for selected centers-of-excellence who will be early adopters of dNerva® targeted lung denervation therapy (“TLD”).  This individual will operate with significant autonomy and will be expected to cultivate strong relationships of trust and integrity within the German-speaking medical community as well as within the company.

Responsibilities:

  • Lead the development and execution of the company’s business plan for the DACH region
    • Develop and execute site-specific market development plans to ensure successful start-up and growth of TLD programs in selected centers-of-excellence in Germany, Austria and Switzerland
    • Explore opportunities and develop a strategic market access plan for TLD introduction in Switzerland and Austria, working with the SVP Global Market Development
    • Recruit, lead and develop team members
    • Assess the market environment and report on competitive activity and intelligence and macro trends with business-level, national or regional impact, as well as German-language publications of relevance to Nuvaira
  • Develop mastery of the Nuvaira product and procedure in order to provide didactic and hands-on physician training as well as proctoring support of cases
    • Assess performance of, and provide input and organized feedback to the company’s training, education, and reporting programs to assure best-in-class service
  • Assess and identify emerging key opinion leaders and strategies to cultivate support with key constituencies within the DACH region
  • Organize meetings, programs and updates to build a strong clinical network of TLD advocates in within the DACH region
  • Evaluate potential commercial expansion centers and strategies, prepare annual operating plans, and execute with accountability to budgets and plans
  • Ensure that the company’s activities and actions are recognized as highly ethical and are widely respected for their track record of achieving positive results

 

 

Qualifications:

  • College Degree required
  • 10+ years of medical device experience in sales and market development leadership
  • Experience and proven capability to proctor interventional clinical cases in the operating theatre and guide physician training and competency development (pulmonary or cardiovascular hands-on proctoring experience preferred)
  • Strong ability to interpret/use/present scientific literature and clinical study results
  • Strong English language ability (written / spoken / medical/technical)
  • Experience in building a commercial team in Germany as well as rolling up sleeves and personally driving key initiatives
  • Experience driving a medical device launch that introduced a new technology/therapy requiring physician education and case support
  • Understanding of German regulatory environment and reimbursement processes, including NUB programs
  • Ability to develop and execute long range strategies designed to achieve competitive advantage, and translate strategies into specific objectives and cost effective operational plans
  • Capability to give concise, clear, and motivational presentations to both internal and external stake holders
  • Proven ability to cultivate an active network of relationships within and outside of the organization
  • Willingness to travel extensively (50%+) within Germany and internationally (Europe/US) as needed
  • Computer skills including proficiency in Microsoft office suite

Preferred Qualifications:

  • Experience with interventional pulmonary devices desired
  • Established network of relationships with key stakeholders (national, regional and local level) in DACH

 

 Physical Job 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.  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 and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Market Development Manager – Germany

Position Summary:

This individual will lead Nuvaira’s strategic market development in the defined territory (half) of Germany.   This individual will be responsible for physician training, education, site management and developing regional and local referral networks as part of our strategic development initiative for selected centers-of-excellence who will be early adopters of dNerva® targeted lung denervation therapy (“TLD”).  This individual will operate with significant autonomy and will be expected to cultivate strong relationships of trust and integrity within the German-speaking medical community as well as within the company.

Responsibilities:

  • Lead the development and execution of the company’s business plan for Germany
    • Develop and execute site-specific market development plans to ensure successful start-up and growth of TLD programs in selected centers-of-excellence in Germany
    • Recruit, lead and develop team members
    • Assess the market environment and report on competitive activity and intelligence and macro trends with business-level, national or regional impact, as well as German-language publications of relevance to Nuvaira
  • Develop mastery of the Nuvaira product and procedure in order to provide didactic and hands-on physician training as well as proctoring support of cases
    • Assess performance of, and provide input and organized feedback to the company’s training, education, and reporting programs to assure best-in-class service
  • Assess and identify emerging key opinion leaders and strategies to cultivate support with key constituencies within Germany
  • Organize meetings, programs and updates to build a strong clinical network of TLD advocates in Germany
  • Evaluate potential commercial expansion centers and strategies, prepare annual operating plans, and execute with accountability to budgets and plans
  • Ensure that the company’s activities and actions are recognized as highly ethical and are widely respected for their track record of achieving positive results

Qualifications:

  • College Degree required
  • 10+ years of medical device experience in sales and market development leadership
  • Experience and proven capability to proctor interventional clinical cases in the operating theatre and guide physician training and competency development (pulmonary or cardiovascular hands-on proctoring experience preferred)
  • Strong ability to interpret/use/present scientific literature and clinical study results
  • Strong English language ability (written / spoken / medical/technical)
  • Experience in building a commercial team in Germany as well as rolling up sleeves and personally driving key initiatives
  • Experience driving a medical device launch that introduced a new technology/therapy requiring physician education and case support
  • Understanding of German regulatory environment and reimbursement processes, including NUB programs
  • Ability to develop and execute long range strategies designed to achieve competitive advantage, and translate strategies into specific objectives and cost effective operational plans
  • Capability to give concise, clear, and motivational presentations to both internal and external stake holders
  • Proven ability to cultivate an active network of relationships within and outside of the organization
  • Willingness to travel extensively (50%+) within Germany and internationally (Europe/US) as needed
  • Computer skills including proficiency in Microsoft office suite

Preferred Qualifications:

  • Experience with interventional pulmonary devices desired
  • Established network of relationships with key stakeholders (national, regional and local level) in Germany

 

Physical Job 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.  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 and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.