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Clinical Software Development Specialist ** 100% Remote **

Company: Amerit Consulting
Location: Raleigh
Posted on: May 15, 2022

Job Description:

Overview:
Our client, a global leader in development and manufacturing of medical devices & Treatments for Chronic diseases / Respiratory disorders / Sleep-disordered breathing, seeks an accomplished Clinical Software Development Specialist.

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*** Location: San Diego, CA 92123 (100% Remote Acceptable)*** Duration: Direct Hire / Permanent / Full-time Notes: - 1st Round: HireVue Video interview & 2nd Round: 30-minute Zoom/ Video with Manager. - This is a remote position, but the candidate must be located within the PST time zone. It is highly preferred if the candidate is local to San Diego, but this is not a requirement. - The candidate can be a recent graduate. The hiring manager is not necessarily looking for someone with a ton of experience. He wants someone that can grow with the team. Description: - This position will support the medical affairs team. Most of the team is located in Sydney, Australia and Singapore. - As new software is released for these products, this position and team assesses how the software update affects the end user (patients, provider, etc.) - they are assessing if there is a clinical impact. - The primary role of Clinical Studies and Development is the oversight, administration, and execution of the approved clinical study plan. This will include all aspects of the execution of the study, such as contracting, documentation, site visits, and report writing. This role may be as a Study Manager, Clinical Trials Associate, or other similar role. - As a Clinical Development Specialist (digital), you will be part of a fast-paced learning environment where teamwork is paramount. You will be a key part of teams developing new products and solutions in digital health and medical devices that will help millions of patients to breathe better. - To provide clinical input into product development across business units to ensure the safety, efficacy, and usability of products. - To support the research, project management and conduct of clinical studies and usability evaluations - Liaise with client groups (Product Development, Product Management, Marketing, Regulatory, Research Teams) to provide clinical support. - Develop and draft clinical trial protocols, ethics documents, and trial reports. - Provide clinical input to support the ongoing life of existing products (i.e.. risk assessments, field complaints, marketing material, clinical evaluations). - Serve as the clinical subject matter expert (SME) during internal & external audits. - Develop white papers, conference posters, journal papers, and other scientific literature. Qualifications: - Bachelor's degree in Medical/Health Science or Bioengineering ideally with some exposure to clinical environments and/or digital health. - The candidate should have a background in software and some kind of scientific background. - They should have experience working with software programs (either through a prior job or even undergrad research). - They should have enough of a working knowledge of software to be able to talk to software developers and understand the terms being used. - This role is not clinical study/trial heavy, but the candidate should understand (or at least have an interest in) clinical trials and studies. - Some knowledge of sleep & respiratory medicine and its diagnosis and treatment. - Current understanding of digital health applications, AI, & machine learning would be helpful. - Good analytical and communication skills. - Ability to learn and develop in a distributed team environment across geographies and time zones. - Some travel may be needed. - Preferred: A good understanding of medical device product or software development.
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I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.
Satwinder "Sat" SinghLead Technical Recruiter
Company Overview: Amerit provides consulting, temporary staffing and payrolling services to Fortune 500 companies nationally. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.
Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

Keywords: Amerit Consulting, Raleigh , Clinical Software Development Specialist ** 100% Remote **, IT / Software / Systems , Raleigh, North Carolina

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