Clinical Development Scientist Job at Insight Global, Washington DC

aGVzOFB1c0I2bUJuUFFldEUxN2o0cU0wWmc9PQ==
  • Insight Global
  • Washington DC

Job Description

Hybrid role in Bothell, WA or Cambridge, MA (3X/WEEK)

Clinical Development Scientist - 1 year long contract +!

Requirements:

  • An MD, PhD/MS Degree in Biomedical science with a scientist background
  • 7+ years’ experience in clinical research/development/real world evidence (RWE) function
  • Strong scientific background in medical device space who has designed studies for regulatory environments (U.S. REGULATIONS REQUIRED)
  • Experience in Machine Learning / Artificial Intelligence algorithm clinical performance validation

Day to Day:

The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence.

  • Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.
  • Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.
  • Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data.
  • Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.
  • Ensure appropriate preparation, interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.
  • Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.

Job Tags

Contract work,

Similar Jobs

Carson

Creative Manager Job at Carson

 ...Creative Manager to develop lines of consumer goods. Such items are sold to our customer base of gift retailers, souvenir shops, florists and specialty stores across the United States.Example product lines include bereavement gifts, home dcor, chimes, garden and seasonal... 

AAA Southern New England

Field Travel Agent 1 - Charleston Job at AAA Southern New England

 ...Branch offices present a unique dynamic for selling* Walk-in traffic also provides the chance for selling opportunities daily* Field Travel Agents receive 100% backing from one of America's most trusted brands to include paid training* Travel Partner Training... 

Knight Electric, Inc

Electrician (Travel) Job at Knight Electric, Inc

 ...Alpharetta, GA About this role: We are currently looking for Electricians to work and lead commercial electrical construction projects....  ...a plus. You can live in any city in the Southeast US and travel to job site. Travel is paid along with per diem and mileage (... 

Insurance Recruiting Solutions

Assistant Vice President Actuarial Job at Insurance Recruiting Solutions

 ...ABOUT THE ROLE AM Best A rated regional property casualty carrier seeks Actuarial professional to lead Actuary department. Reporting to the Chief Financial Officer, the AVP Actuarial will lead actuarial, pricing, modeling, and data analytics functions. The AVP Actuarial... 

Strategic Staffing Solutions

Solar Technician Job at Strategic Staffing Solutions

 ...SOLAR TECHNICIANS NEEDED IMMEDIATELY IN TAMPA, FL WITH MAJOR UTILITY COMPANY! 9 POSITIONS AVAILABLE! EXCELLENT COMPENSATION AND BENEFITS PROVIDED! ALL ROLES ARE DIRECT HIRE, PERMANENT OPPORTUNITIES!***PAY RATE - $38.31 PER HOUR - (PLUS FULL HEALTH BENEFITS, UNION COVERAGE...