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Clinical Affairs Consultant
Insight Global - Bothell, WA
posted about 2 months ago
About the position
The Clinical Affairs Consultant plays a critical role in leading the development of evidence generation strategies for clinical projects within a hybrid work environment. This position requires a strong scientific background and extensive experience in clinical research and development, particularly in the medical devices sector. The consultant will work closely with cross-functional teams to ensure that clinical studies meet regulatory requirements and yield actionable insights for stakeholders.
Responsibilities
- Lead the development of evidence generation strategies for assigned projects.
- Deliver Clinical Development Plans that outline clinical evaluation plans according to internal and external requirements.
- Collaborate with internal and external stakeholders to ensure studies yield well-founded conclusions.
- Design and develop study protocols in compliance with project standards and regulatory guidelines.
- Manage and oversee study execution, analysis of results, and generation of final study reports.
- Deliver assigned clinical programs in partnership with Clinical Operations.
- Lead the development and dissemination of evidence generated from clinical evaluation plans.
- Conduct discussions with regulators regarding clinical evidence and epidemiology/surveillance.
- Stay current with regulatory guidance and requirements globally.
- Support the Medical Safety function for signal detection and evaluation.
- Advance the Philips Data network strategy by developing innovative data partnerships.
- Create systematic processes for data infrastructure efficiency.
Requirements
- MD, PhD/MS Degree in Biomedical Science or Epidemiology strongly preferred.
- 7+ years of experience in clinical research/development/real world evidence (RWE) function, preferably in medical devices.
- Strong scientific background in evidence generation and clinical evaluation methodologies.
- Experience in innovative clinical trial design, registries, and quality improvement initiatives.
- Working knowledge of biostatistics.
- Experience in Machine Learning/Artificial Intelligence algorithm clinical performance validation.
