Clinical Trainer (Openings available in San Francisco CA, Los Angeles CA, Houston TX, Dallas TX, El Paso TX, Chicago IL, Philadelphia PA, Pittsburgh PA, Charlotte NC, Raleigh NC, Charleston SC and Columbia SC)
Are you prepared to join a cutting edge, dynamic team that is innovating and disrupting the med-tech field? SANUWAVE is hiring motivated, passionate, high preforming individuals to support the commercialization of its newly approved FDA devices! If you think you are ready to join a face-paced, growing company with high energy and tremendous potential upside, then consider joining us at SANUWAVE.
SANUWAVE Health, Inc. is an emerging leader in the development and commercialization of a high-energy focused, shock wave technology that is used in devices for the repair and regeneration of bones, muscles, tendons and skin, and for the separation of solids and fluids in non-medical systems. Headquartered in Suwanee, GA, SANUWAVE designs, manufactures, markets and services its industry leading products for worldwide distribution.
We are looking to fill an open Clinical Trainer role.
The Clinical Trainer serves as the primary point of contact for Clinical education and service to internal and external contacts by driving SANUWAVE business goals through developing training programs and supporting integrated clinical programs that reflect evidence-based medicine.
Ensure the execution of clinical strategies that provide the training and clinical evidence necessary to successfully market new products in an increasingly competitive environment; evaluate potential licensing and acquisition opportunities; meet regulatory requirements for market entry; provide guidance for first-in-human use studies, develop training program and provide training externally where devices are placed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Travel to various locations mostly domestically (possibly internationally from time to time) to train external users on our devices.
- Assist with the development of training certification program including web based interactive components such as blogs and chat rooms.
- Assist with the design, integration, and execution of the portfolio of clinical studies, adhering to the highest standards of regulatory and ethically-based clinical research.
- Stay current with the therapeutic areas of focus and apply knowledge of the scientific literature and health economics issues to the development of clinical strategy and study design.
- Sustain awareness of the breadth of SANUWAVE clinical work globally, looking for opportunities to leverage it across the product portfolio of SANUWAVE.
- Build relationships in the medical community to cultivate study partners and resources.
- Maximize corporate performance and minimize risk through the application of their scientific discipline and expert influence for the business needs of SANUWAVE.
- Enable business strategy by designing, planning and executing clinical strategies aligned with SANUWAVE’s business needs.
- Assist with the clinical study parameters, deliverables and direction, and provide guidance, expertise and oversight support to Clinical Affairs personnel.
- Build relationships and represent SANUWAVE in the medical and scientific community, cultivating outside partners and resources for clinical studies.
- Demonstrate leadership to enhance team processes and work across functions to accomplish the goals of Clinical Affairs, and SANUWAVE.
- Other duties as assigned by management.
Knowledge, Skills and Abilities
- Ability to travel up to 75% of the time.
- Ability to work a flexible schedule that may require weekend and evenings as needed.
- Demonstrate an understanding of the business, marketing, L&A, regulatory and healthcare economics strategies of SANUWAVE.
- Influence good business decisions by articulating and positioning evidence based clinical data as a competitive tool and driving the appropriate clinical strategy.
- Proactively contribute clinical input into cost/benefit analysis and resource management to support project prioritization as part of existing and new product development process.
- Translate business needs into responsive cost effective clinical strategies that are designed to provide competitive advantage and meet product innovation, regulatory submission and commercialization needs.
- Constructively challenge issues and influencing strategy based on a comprehensive clinical knowledge base, effectively applied to the business context.
- Professionally define clinical study parameters, deliverables and direction, and provide guidance, expertise, and oversight support to Clinical Affairs personnel by:
- Skillfully designing clinical studies aligned to business needs and outside regulatory agencies, including protocol development, investigative site selection criteria, and publication of results.
- Establishing and managing therapeutic portfolio priorities, milestones and time frames for clinical studies, consistent with SANUWAVE business needs.
- Overseeing and/or being actively involved during clinical studies, providing general direction, supporting problem identification and resolution.
- Analyzing and interpreting clinical study results, utilizing appropriate tools and methods, and culminating in the clinical evidence needs of the business.
- Ensuring that the highest scientific, medical, and ethical standards are adhered to in all clinical studies.
- Build relationships and representing SANUWAVE in the medical and scientific community, cultivate outside partners and resources for clinical studies by:
- Professionally representing SANUWAVE through active participation in the corporation and medical community.
- Developing, sustaining and providing value to relationships with physicians respected in their field.
- Making professional presentations both internally and externally pertaining to clinical research.
- Actively participating in and providing leadership to pertinent professional organizations.
- Demonstrate leadership to enhance team processes and work across functions to accomplish the goals of Clinical Affairs, and SANUWAVE by:
- Effectively participating in appropriate SANUWAVE new technology assessment and development activities in support of SANUWAVE business goals.
- Skillfully mentoring and collaborating to assure appropriate training of staff to comply with federal agency regulations and develop biomedical skills/knowledge, new technologies and medical procedures.
- Professionally working with multiple levels and across functional areas to attain SANUWAVE goals and objectives.
- Actively modeling positive team behaviors in order to influence relationships to effect constructive change and align recommendations with departmental and SANUWAVE business strategies.
- Effectively enforcing Clinical Affairs policies/procedures, escalating as appropriate.
- Successfully identifying and working to resolve conflict through effective communications and negotiation.
- Actively promoting process and procedure improvement within Clinical Affairs and SANUWAVE as appropriate.
- Take initiative to maintain relevant certifications and to respond to needs identified in individual development plans through continuing education.
- Strong sense of accountability including time management, meeting deadlines, and the organization of multiple projects at the same time.
- Ability to report and analyze data including creating and delivering factual, compelling and analytical presentations in PowerPoint.
- Strong interpersonal skills and business acumen including medical and technical aptitude.
- Strong and efficient organization specifically with travel planning and travel expenses
- Ability to communicate well with customers.
- Strong verbal and technical writing skills, attention to detail and accuracy.
- Ability to demonstrate success with previous quality management systems, documentation and process improvement.
- Ability to multi-task, use sound personal judgment, reason and logic. Exhibit adaptability.
- Comprehensive knowledge of ISO, GCP, ICH, FDA, and other applicable regulations governing the conduct of clinical trials.
- Anticipates issues and organizes and leads other members of the team to resolve problems.
- Good command of English language
- Excellent oral presentation/public speaking skills
- Must be extremely flexible and able to rapidly change priorities
- Ability to interact effectively with others
Qualifications (Experience, Education, Licenses and Certification)
- Licensed RN, LPN, NP or DNP preferred.
- A minimum of 10 years with in a science or related technical field to include clinical training.
- Medical device experience is required.
- Must be able to travel domestically approximately 75% of the time, per year (on average) with some international travel too.
SANUWAVE is an Equal Opportunity Employer.
Please email your resume to email@example.com and include the title of the job in the subject line.
Qualified applicants will be contacted.