Clinical Research Scientist
Adecco Medical & Science is a specialized medical division of the Swiss owned company Adecco SA, the 4th largest employer in the world. Our strengths in nursing, paramedical, pharmacy, technical support staff and quality assurance, give us a global platform from which to serve our many Clients. Adecco Medical & Science is currently seeking a qualified and experienced Clinical Research Scientist on behalf of one of Adecco Medical & Science’s top tier clients in the St. Paul, MN area. Job Purpose: The Clinical Scientist evaluates clinical data and authors documentation for medical devices across multiple therapeutic areas. The Clinical Scientist is responsible for development of new, and updating of existing, Clinical Evaluation Reports to support regulatory submissions, risk management processes, and research and development needs. The Clinical Scientist develops and executes clinical trial strategy including designing study methodology, crafting investigational protocol and supporting documentation, and authoring scientific articles and other papers. responsible for the implementation of clinical studies to support FDA and Foreign regulatory submissions [510(k), IDE, PMA, and CE Mark] and marketing activities. The Clinical Scientist provides balanced reviews and reports of clinical safety and performance to internal and external stakeholders. The Clinical Scientist ensures compliance with clinical and regulatory standards and guidelines, and corporate standard operating procedures (SOP) as they relate to patient safety, risk management, and clinical trial design and execution. Technical Knowledge and Skills: Scientific University Degree (BS degree) required Bachelors degree in biological or medical science, or engineering required (A Masters degree is preferred). Expected experience in the medical device industry or pharmaceutical industry (5+ years with BS/BA; 3+ years with MS/MA; 2+ years with PhD/MD/DVM). Solid understanding of scientific/clinical research, the scientific method, and statistical concepts. In-depth knowledge of regulatory process (e.g., IDE, PMA, 510(k), post-market/post-approval), GCP procedures, and legal compliance for pharmaceutical and/or medical device industry. Demonstrated writing capability and critique of clinical and regulatory documentation. Program/project management skills for effective project execution and management. Excellent communication and interpersonal skills, able to establish and maintain effective communications with colleagues, customers, and clinical study site personnel. Facility with general writing and presentation software, clinical trials management software, and business platform software. Must be able to travel up to 20% Apply Online About Adecco North America Adecco is a Fortune Global 500 company and the world leader in workforce solutions. Our comprehensive service offering includes temporary and contract staffing, permanent recruitment, outplacement and career services, training and consulting. Adecco is an equal opportunity employer. Keywords: Biotech
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