Our clients focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseasestherapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
They currently have two vacant roles for Surgical Specialists, where you be required to carry out the following:- Provide surgical training expertise for clinical investigative sites, customers, and the company.
Responsible for the delivery of high-quality surgical training, surgical support and surgical outcomes for pre-market devices under study protocols, through involvement in surgical training processes and materials development, the direct delivery of surgical training and support, and train-the-trainer leadership for the RBM and CRM teams.
Also supports commercial product surgical training by providing train-the-trainer activities.
RESPONSIBILITIES: DIRECT DELIVERY OF SURGICAL TRAINING AND SUPPORT Assures first in class surgical outcomes through the provision of surgical training, mentoring and support to investigative sites, customers, and internal personnel Provide on-site surgical training and support for study surgeons on the implantation and use of investigational product.
Conduct didactic, dry lab, wet lab, and in human surgical training for initial training and refresher training Assess surgical competencies of surgeons and make determinations as to when the surgeon is deemed trained and may be handed to the CRM or RBM for ongoing surgical support or surgical observation.
Provide documentation of study surgical training and competencies Working with Clinical Research, assure an adequate supply of surgical product for each study case.
Working with Clinical Research, assure that study surgeons and OR staff follow surgery and randomization processes according to protocol.
Support all aspects of in the operating room study involvement including identification of study related adverse events.
Maintain necessary accreditations, certifications and qualifications to enter all necessary operating room environments.
Provide on-site surgical training and support for commercial product as required.
Travel as necessary, to include international travel as requested Communicate effectively with site staff, investigators, and consultants.
COMPANY EXPERT IN SURGICAL APPLICATIONS Working cross functionally with all departments to maintain the highest level of expertise in the surgical aspects of all products Support new product development through participation in first in human and early stage development projects from a surgical perspective.
Be available to for remote telephone support for RBMs, CRMs and surgeons.
SURGICAL TRAINING MATERIALS DEVELOPMENT Work with our clients R&D, Engineering and Clinical Affairs in the development of surgical training programs and materials.
Receive field input from surgeons and integrate back into the surgical training programs to ensure continual improvement in our processes, assuring maximum outcomes.
WORK EXPERIENCE: Knowledge of the operating room environment, sterile technique, and decorum Ability to effectively communicate with surgeons both in the OR and outside Ability to effectively train and coach surgeons Knowledge of the FDAs Good Clinical Practices guideline, clinical trials monitoring and regulatory compliance Knowledge of International Clinical Research standards (ISO 14155 Clinical Investigation of medical devices) Excellent problem solving and analytical skills (interpret and summarize data) Excellent written and verbal communication and presentation skills Motivated and able to work independently, as well as within a team Excellent organisational skills Excellent project leadership skills (planning, execution and follow-up) Must be willing and able to travel 80% of the time (estimated) Knowledge of medical terminology and ophthalmology terminology Knowledge of SAE/AE reporting and documentation Meets milestones and schedules Exhibits personal integrity, credibility, and responsibility Perform any other related duties as assigned or required.
Minimum 2 years relevant work experience in the medical device industry, experience in the surgical ophthalmology field given high preference.
EDUCATION: Bachelor's Degree in biological science, nursing or other health-related discipline preferred.