Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8™, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.
Mainstay Medical is seeking a Clinical Scientist who will provide Spine and Neuromodulation knowledge to assist in the execution of programs for evidence generation and clinical study design to support commercialization, regulatory submissions, publications, and conference presentations. The Clinical Scientist will provide input for the design of post market research opportunities and participate in strategic decisions related to clinical evidence to support product development, as well as collaborate with various internal stakeholders (Clinical Project Management, Regulatory, Clinical Communication, Quality, and the Field Sales team) and external stakeholders (including physicians and site research staff). The Clinical Scientist role is based in San Diego, CA., and reports to the Head of Research.
- Assist in the management of the research process through the various stages from inception to publication and participate in the development of research plans to support the company objectives.
- Generate, document, and communicate development plans for critical aspects of a project including maintenance of appropriate document control and quality standards.
- Conduct site initiation visits: train site personnel on study conduct, participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
- Work with research sited to pre-empt or identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study protocols, including attending implantations, follow-ups and assessments when required.
- Collate, analyse data, interpret results, and present findings in a professional and knowledgeable manner.
- Prepare detailed technical procedures, protocols, reports and assist in the preparation of manuscripts and abstracts for submission and publication in peer reviewed scientific journals. Prepare and assist with preparation of slide presentations, and poster presentations for scientific meetings/congresses worldwide.
- Provide scientific input into the content and design of marketing materials.
- Assists in the organization and management of Investigator Meetings for assigned studies.
This role is responsible for executing on programs related to clinical study design, support commercialization, regulatory submissions, publications, and presentations. You will provide input in the design of post market research and provide input related to strategic decisions tied to clinical evidence in support of product development. You will interact with Clinical Project Management, Regulatory Affairs, Clinical Operations, Quality and Field Sales organization. This is a key role in support of the value of the ReActiv8 therapy to external and internal clients, such as physicians, scientist, and other interested parties.
- Teamwork – Able to collaborate with all functions within an organization.
- Integrity – Handle confidential information in an effective manner.
- Innovative – Use creativity to problem solve and be agile to adapt to changing business.
- Leadership – Able to lead by example. Establish credibility within the organization and lead others when warranted.
- Undergraduate Degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); with 4+years of equivalent work experience, required.
- Master’s Degree in clinical, health or science disciplines with 2-4 years of relevant experience.
- Successful in technical proficiency, scientific creativity, collaboration with others, and independent thought and ability to defend scientific ideas.
- Strong knowledge of clinical research process.
- Excellent, presentation, organizational and interpersonal skills.
- Knowledge of ICH / GCP regulations.
- Self-starter, ability to work in a fast-paced, competing deadline driven environment.
- Proficient in Microsoft Office Suite and Internet for business use.
For further information on Mainstay Medical, please visit our website: www.mainstaymedical.com
Come join a growing and thriving organization! We foster an exciting culture founded on teamwork, bias for action, urgency, and accountability, which allow us to develop meaningful and lasting relationships with our colleagues, the Doctors and Patients we serve.
We offer a competitive package. Our core benefits include Medical, Dental, Vision, 401(k) Retirement Savings, Life and Short-Term Disability, PTO.
Forward your cover letter and resume to: firstname.lastname@example.org
Subject Line: Clinical Scientist
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