Clinical Science Specialist – Remote – 445784

Revel IT

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OUR GOAL: 
Treat our consultants and clients the way we would like others to treat us — we are honest, stay true to our word, and work in the best interest of our clients, consultants, and candidates. Many say they work this way, but few actually do. We are a company that does. Additionally, we bring joy to the world of IT staffing and IT recruiting by making the hiring experience memorable, fun, and different. 
 
OUR MISSION:
Find and provide the best talent for clients and excellent career opportunities for consultants and candidates — whom we treat as part of our team. Interested in joining our team? Check out the opportunity below and apply today!
  
Reference: 445784
  
Clinical Science Specialist – Remote

In this role, the successful candidate will be able to independently collect, organize, and evaluate relevant scientific and technical information, including performance data, to prepare documentation in support of development and global registration of in vitro diagnostic medical devices. The Clinical Science Specialist will be responsible to critically review and summarize information and apply appropriate scientific principles to guide study planning and complete performance evaluation documentation.

ESSENTIAL RESPONSIBILITIES:

  • Peer-reviews device performance plans, study protocols, reports, and presentations. Coordinates cross-functional review and approval of documents in the document management system. Stays informed of performance evaluation requirements published or communicated by major Health Authorities (HAs). 
  • Conducts scientific literature reviews, objectively evaluates performance data, and prepares documentation for in vitro diagnostic products in support of product development and global registration.
  • Documentation may include intended use statements, clinical validation plans, pre-submissions to the US FDA, performance evaluation documentation supporting compliance with the European IVDR (scientific validity reports, clinical performance reports, performance evaluation reports), as well as product instructions for use.
  • Demonstrates understanding of intended uses of in vitro diagnostics and their application in clinical practice and applies this understanding to critical review of data and preparation of plans and reports.
  • Peer-reviews documentation to ensure high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
  • Coordinates timely review and approval of documents within the document management system.
  • Works with a cross-functional team (eg, Regulatory Affairs, Development, Medical Office, Quality, Marketing) to ensure timely completion and approval of clinical evidence documentation required for product registration.
  • Miscellaneous duties and special projects as assigned, including deliverable tracking, process improvement, development of document templates and educational tools.
  • Tracks progress of assigned deliverables to ensure timelines and other project team needs are met.

Requirements:

  • Minimum of 2 years’ experience in study design, data interpretation, and report writing for clinical or non-clinical studies.
  • Minimum of 2 years scientific writing experience (e.g. manuscripts, book chapters, grants, clinical study protocols and/or reports)
  • Bachelor’s in the biomedical or life sciences; Master’s, PhD or PharmD preferred
  • Must have excellent writing skills and the ability to communicate correctly and effectively in English, and to use medical terminology accurately.
  • Ability to quickly acquire and apply understanding of in vitro diagnostic device portfolios, business objectives, technical skills, clinical data/evidence.
  • Ability to manage multiple projects, interact with multi-disciplinary teams, and operate within a fast-pace environment.
  • Requires in depth working knowledge of software programs used to prepare documents (Microsoft Word, Adobe Acrobat Professional, EndNote)
  • Knowledge of literature databases and methods for systematic literature review.
  • Ability to quickly develop expertise in the company’s internal document management system.
  • Be passionate about improving the lives of all patients afflicted with cancer.
  • Excellent written and verbal communication skills.
  • Strong work ethic and demonstrated ability to deliver assignments on time.

Desired: 

  • Experience writing reports for regulatory submissions and marketing applications is a plus.
  • Experience in the in vitro diagnostic device industry, and/or immunohistochemistry, histology, cancer biology/oncology is desirable.
  • Knowledge of statistical basis for diagnostic device performance characteristics preferred.
  • Knowledge of biomarker characterization, diagnostic testing laboratory workflow, histology, immunohistochemistry, and molecular biology preferred.

  
  
  
ABOUT REVEL IT:
Revel IT (formerly known as Fast Switch) is one of the fastest-growing, privately held, IT Staffing companies in the nation. Our client base includes 32% of the Fortune 25. We have major offices in Dublin, OH, Tucson, AZ, Los Angeles, CA, and Austin, TX and are rapidly expanding into new markets from coast to coast.
 
  
WHY REVEL IT: 

  • In addition to standard health and 401k benefits, we offer referral bonuses and training/continuing education opportunities.
  • 5-year client retention: 99%
  • No. 1 supplier with customers: 53%
  • Top 3 supplier with customers: 77%
  • Consultant retention: 94%

  
We do our jobs in a way that brings delight every day to our clients and the people who work with us. Life is simply too short to grind through every day as a small cog in a huge recruiting machine. As a young and high energy company, we aim to help consultants and candidates land fulfilling jobs that offer real career growth.
  
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