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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

  • Supervise team members when necessary

How will you get here?

Education:

  • BA/BS Degree, 7+ years/ MS Degree, 5+ years/ PhD Degree, 3+ years of industry experience in Clinical Research, Research & Development, or related job in Medical Device or Pharmaceutical industries.

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

  • Understanding of Quality Systems Regulations and GCP procedures

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

  • Must be tolerant to change, ready to take on new challenges and open to learning new skills

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

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