Clinical Affairs Expert

1 month ago


Cambridge, Massachusetts, United States Insight Global Healthcare Full time

Job Overview

Clinical Affairs Consultant - 8 month contract + possible extensions/conversion. Hybrid role, 3X week on-site in Bothell, WA or Cambridge, MA.

About the Role

As a Clinical Affairs Consultant, you will play a key part in generating evidence to support Philips' regulatory clearances, claims, and market access. You will lead the development of evidence generation strategies for assigned projects, working closely with internal and external stakeholders.

Key Responsibilities:

  • Develop and implement clinical evaluation plans to deliver high-quality evidence.
  • Design and develop study protocols in compliance with regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR).
  • Manage and oversee study execution, analysis of results, and generation of final study reports.
  • Deliver clinical programs, working in partnership with Clinical Operations.
  • Lead the development and dissemination of evidence generated from clinical evaluation plans.
  • Maintain current knowledge of regulatory guidance and requirements.

Requirements:

To be successful in this role, you will need:

  • A medical degree (MD) or PhD/MS in Biomedical science, Epidemiology.
  • At least 7 years of experience in clinical research, development, or real-world evidence (RWE) functions, preferably in medical devices.
  • Strong scientific background in evidence generation and clinical evaluation/RWE methodologies.
  • Experience in machine learning/artificial intelligence algorithm clinical performance validation.

What We Offer:

  • An estimated salary range of $120,000 - $180,000 per year.
  • Opportunities for career growth and professional development.
  • A dynamic and collaborative work environment.

About Insight Global Healthcare

We are a leading healthcare staffing firm dedicated to connecting talented professionals with top healthcare organizations. At Insight Global Healthcare, we value our employees' skills, expertise, and passion for delivering exceptional patient care.



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