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| DESCRIPTION |
| · Lead/assist with clinical data collection and analysis, and clinical and technical report writing· Work with Clinical Research, Marketing and New Product Development teams to design and see through relevant clinical studies that demonstrate benefits, safety, and efficacy of OMNI’s robotic and implant products· Develop clinical study protocols, budgets, IRB submissions with associated documentation (informed consent forms, continuing reviews)· Travel to clinical sites to assist with New Product Evaluations and Clinical Data Collection; conduct site initiation visits, annual study monitoring visits, study closeout visits· Works with electronic clinical data collection systems, including Patient Reported (PRO), physician reported, hospital and/or physical therapist reported outcome measures.· Analyze datasets of clinical data to explore and develop relationships and correlations between inputs and outcome parameters· Lead the development of Clinical Evaluation Plans and Clinical Evaluation Reports, compliant with MEDDEV 2.7.1 rev 4· Following-up with clinical collaborators to see studies through to completion· Lead and author scientific publications in Peer-reviewed journals, and national and international conferences |
| Bachelor’s degree in Applied Science, Biological Science, Engineering, Mathematics, BioStatistics, Informatics, Health Sciences, or relevant field of study required, Master’s preferred. Minimum of five 5 years of relevant experience and minimum 3 years in medical devices/research preferred. Experience in medical device industry, Orthopedics, and Knee and Hip Replacement strongly preferred. |
| · Knowledge of basic statistical analysis methods, such as regression analysis, ANOVAs, calculating correlations, confidence intervals, power analysis, Kaplan–Meier analysis, experience with statistical processing software (such as SAS, R, minitab or similar) · Experience in clinical research and orthopaedic biomechanics/science, with the ability to conduct pre- and post-market clinical studies, including formulation of relevant research questions, performing study design and power analysis, leading data collection and data analysis, presentation of results, discussion, performing literature reviews· Experience in the Code of Federal Regulations (CFR) or ISO 14155 for conducting clinical research trial is preferred · Familiarity with clinical data and scores, patient reported outcomes (PROs)· Good understanding of clinical research science and processes along with an understanding of product development processes, knee and hip replacement market environment, and clinical trends is required· Ability to provide strategic and scientific clinical research input across New Product Development and Lifecycle Management projects, with a track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required · Advanced technical writing skills, such as scientific publications, is required · Proven effective verbal, written and presentation communication skills.· Demonstrated ability to establish and maintain credibility, trust, and positive relationships.· May required up to 35% of domestic travel. Some international travel may be required. Signed-Ken Smith, Director of Human Resources, OMNIlife Science, Inc. email: ksmith@omnls.com |