PURPOSE OF JOB: Individual will be a member of an outstanding technical team and be the primary conduit for surgical technical information to and from the clinical environment including the operating room and clinic. Individual will be responsible for all aspects of Investigator and clinical staff training, certification and product device technical support to ensure optimal patient outcomes. Individual may contribute to clinical development programs on multiple levels as an integral member.
Key Accountabilities: In this position, you will be primarily accountable to consistently and effectively:
● Provide master level device and surgical training, education and ongoing support to investigators and clinical staff on the use and application of company technology to the highest ethical and professional standards and in accordance with guidelines and direction.
● Work with company and clinical sites to support clinical trials involving Roche drug delivery device(s).
● Work with engineering, clinical and device teams to develop quality resources and knowledge assessment tools for the training of physicians and clinical support staff.
● Collect and internally communicate technical surgical information and feedback from clinical investigators.
● Continuously increase knowledge of new developments within the assigned market as well as company developments in order to function as a subject matter expert
Example Responsibilities in this position, you could:
● Attend implantation/refill/explantation of the surgical device, meaning you are present in the Operating Room and clinic to support and instruct the Investigator, operating and clinic staff.
● Provide remote and on-site support and training of surgical staff during the use of the device/system.
● Prepare and communicate to manager on a timely and regular basis: o Summary of field activities. o Input on travel, budget and other resource requirements.
● Manage busy travel schedule and remote support capabilities
● Identify needs as they arise, propose solutions and complete special projects. Strategy/Planning:
● Build and cultivate important working relationships:
Externally with assigned clinical sites and staff in order to support Phase I, II, III & IIIb studies o Internally, with cross-functional partners, such as Medical Science Liaisons, Product Development, Clinical Operations, Device Development, Research and Early Development teams, or other Medical Affairs groups.
● Help to advance the development of Roche Drug Delivery Devices o As appropriate, advise on the design and development of clinical trials and investigations involving other Roche drug delivery device(s)
- Evaluate, review and propose revisions to protocols in support of the development of the assigned drug delivery device(s).
- Participates on cross-functional teams in the evaluation, field verification, implementation and enhancement of products o Utilize the learning’s and feedback from early Phase Trials to advise the development of technical support for later stage clinical trials and eventual commercialization.
- Serve as the technical expert of site feasibility assessment for clinical trials involving Roche drug delivery device(s).
- EDUCATION REQUIREMENTS:
- Bachelor’s Degree in a clinical/science concentration, education, communications, or equivalent combination of education and experience preferred Required Experience/Knowledge/Skills
- Five years experience in ophthalmic Surgical and/or clinical setting
- Outstanding ability and desire to teach, demonstrated by possessing selfconfidence and effectiveness with a wide variety of student types
- Able to travel 70-80% of the time (may be 3-4 days/week within US)
- Be proficient in GCP (Good Clinical Practice), Adverse Event reporting and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use).
- Maintain all necessary certifications and hospital vendor credentialing including, but not limited to:
- HIPAA Certification o Blood Bourne pathogen o Infection Control and Aseptic Technique o Fire Safety o Individual Institutional Requirements
- Able to interact professionally and effectively with customers, physicians, nurses and other medical staff
- Able to work independently from a remote environment
- Excellent attention to detail, possessing good organizational and time management skills
- Computer skills necessary to generate reports, presentations, spreadsheets, etc.
- Ability to communicate clearly and concisely in written and verbal communications
- Highly motivated and flexible team player with focus on the success of others.
- In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening).
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