Associate Clinical Specialist - exp

The Associate Clinical Specialist will be responsible for developing clinical plans which support New Product Development. This entails seeking and evaluating clinical risk inputs from relevant sources (e.g. published literature, clinical experts). The candidate will be collaborating with a cross functional team comprised of R&D, Marketing, Regulatory and Quality. The candidate will be responsible for documenting the Clinical deliverables / needs which fulfill regulatory requirements, quality needs and marketing needs. The candidate must have experience with, and maintain current knowledge of, US and international regulations, requirements and guidance associated with clinical research, scientific publications and clinical regulatory document preparation and submissions.?
The Associate Clinical Specialist will lead clinical research efforts in the development and execution of strategies to obtain information and support concerning medical devices undergoing or requiring clinical investigation, post market surveillance, or marketed / product use evaluation for the purpose of facilitating worldwide registration and introduction of new products. The candidate will assist in executing study agreements, maintaining timelines, and review of interim and annual reports to track study progress, as well as an active participant in global clinical discussions. The candidate will ensure compliance of research efforts with federal and applicable regulatory agency requirements, GCP, and SOPs.?
? 3-5 years clinical research experience, medical device industry strongly preferred?
? Working knowledge of design controls and product realization requirements for New Product Development?
? Working knowledge of study conduct (post market and IDE), GCPs, ICH guidelines, FDA regulations, and EU regulations which govern clinical activities?
? Demonstrated success in representing Clinical Affairs on a cross-functional product development team?
? Excellent written and verbal communication skills?
? Excellent interpersonal and organizational skills?
? Detail oriented?
? Understanding of medical terminology required?
? Knowledge of statistical concepts and techniques?
? Evidence of medical writing career development such as American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training a plus?
? Computer proficiency for work tasks (Office Suite Programs)?
? Bachelor?s degree in a health-related or scientific discipline, nursing degree, or equivalent education and training.?
? Certificate Degree in Clinical Research or CCRA (Certified Clinical Research Associate) credentials a plus


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