Staff Scientist, Clinical Studies
Company: Thermo Fisher Scientific Inc.
Location: South San Francisco
Posted on: June 7, 2021
|
|
|
Job Description:
Job Description Staff Scientist, Clinical Studies ThermoFisher is at the forefront of the global response
toCOVID-19. We are working with governments, agencies, industry
partners and researchersglobally to ensure priority access to
instruments, consumables, safety supplies and other productsto
address the outbreak. This key role will play a valuable part in
our efforts. Do you have a passion for innovative ideas and groundbreaking
discoveries? Now is an exciting time to join our Genetic Sciences
business. With over $1 billion invested annually in R&D, at
Thermo Fisher Scientific you'll help solve some of the world's
toughest challenges. We empower our teams to put science into
meaningful action and give our R&D colleagues the autonomy,
resources and tools they need to take science a step beyond. US - South San Francisco, CA Genetic Testing Services How will you make an impact? The Genetic Testing Solutions is seeking an experienced and
highly motivated Clinical Study Scientist to work on a team
validating qPCR based microbial detection applications for
regulated markets. The candidate will have a strong understanding
of regulated product development (CE-IVD or US IVD) and QSR
systems, a broad understanding of molecular biology and/or
biotechnology, strong writing skills, and the ability to
collaborate effectively as part of a cross functional team
including R&D, Clinical Affairs, Regulatory Affairs, Product
Managers, and external partners What will you do? Write protocols and reports required for clinical evaluation
studies of regulated products Provide technical guidance during interactions with US FDA and
other regulatory bodies Develop plans and process documentation that meet IRB
requirements to establish clinical trial sites Prepare training materials and conduct technical trainings for
the clinical trial sites, and design experiments required to
support clinical studies Work with clinical sites, Clinical Affairs, or CRO's to review
and troubleshoot data and ensure compliance with study
protocols How will you get here? Education: Experience Strong experience in qPCR and other IVD Diagnostic tests Understanding product design, development and commercialization
for molecular diagnostic products Familiarity with the process of obtaining CE-IVD and/or FDA
clearance/approval of In Vitro Diagnostic (IVD) products,
preferably in molecular diagnostics Knowledge, Skills, Abilities Proven expertise in data analysis and ability to interpret and
summarize scientific results in a clear and accurate manner Good writing skills, excellent time management skills, and
ability to work independently required Excellent organizational skills, including the ability to
efficiently evaluate, prioritize and handle multiple
programs/studies and coordinate with multiple internal and external
teams Driven to deliver quality results on time and in a highly
ethical and professional manner Demonstrated resourcefulness, strategic and analytical thinking,
and directed toward achieving objective Excellent verbal and written communication skills and the
ability to interpret and summarize scientific results in a clear,
concise, accurate manner Our global team of more than 75,000 colleagues delivers an
unrivaled combination of innovative technologies, purchasing
convenience and pharmaceutical services through our
industry-leading brands, including Thermo Scientific, Applied
Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and
Patheon. For more information, please visit
www.thermofisher.com.
Keywords: Thermo Fisher Scientific Inc., South San Francisco , Staff Scientist, Clinical Studies, Other , South San Francisco, California
|
Click
here to apply!
|
