San Jose, United States
Permanent | Full Time
Job Title: Clinical Research Scientist
Duration: Temp 6-12 months
Job Location: Sunnyvale, CA
The Clinical Research Scientist develops and writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products. The scientist works on complex projects requiring state of the art knowledge in infectious diseases and oncology molecular diagnostics.
• Work closely with cross-functional teams (Clinical Affairs, Medical Affairs, Regulatory, R&D, Quality) to strategize and compile clinical data to support current and new products submissions per EU Invitro Diagnostics Device (EU IVD) regulations.
• Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
• Assess clinical evidence and state of the art in medicine related to the products and intended use to demonstrate safety and performance.
• Develop and write high quality clinical plans and reports with minimal supervision. Support development and drafting of clinical study protocols, and other study materials as needed.
• Collaborate with a multidisciplinary team in the development and, creation of study protocols in clinical procedures
• Prepare scientific content of clinical study reports
• Review clinical section for regulatory submissions
• Conduct comprehensive literature searches for product/technology evaluations and will write ad hoc reports based on these literature searches towards regulatory submission.
• Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US and EU regulation as well as with policies and procedures.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES):
• Bachelor’s, Masters or PhD or equivalent experience
• 2-3 years of relevant experience in the medical device or diagnostics industry, in particular within clinical development
• Experience with in vitro diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics and oncology
• Strong interpersonal, written communication, and presentation skills
• Good problem-solving skills
• Performance oriented with ability to work along agreed timelines with a focus on execution
• Fluent in English (verbal and written communication) and proficient in scientific writing, editing, proof reading skills, including spelling, grammar and formatting
• A Bachelor’s, Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
• Strong scientific background with deep understanding of infectious diseases, oncology and the molecular diagnostic area
• Preferred experience in IVDD/IVDR or MDD/MDR regulations
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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