- Primary responsibilities include:
• Coordinating global COA/PRO strategic plans to align with product franchise goals. - Assisting in selecting or developing COA/PRO instruments for studies.
- Guiding the implementation of COA/PRO instruments following company processes.
- Managing COA/PRO sections in evidence packages for regulatory submissions.
- Developing, validating, and implementing instruments for measuring COA/PROs in clinical trials or studies.
- Conducting literature searches to support COA/PRO endpoint strategies.
- A Clinical Outcome Assessment (COA) Instrument is a formal perception-based clinical assessment tool that quantifies a study participant's health outcome.T
- Types of COAs: Patient-reported outcome (PRO) measures. Observer-reported outcome (ObsRO) measures.
- Clinician-reported outcome (ClinRO) measures.
- Performance outcome (PerfO) measures. PROs offer direct patient-reported health information.
- Patient-reported data. Existing questionnaires used in studies.
- Key qualifications: COA endpoint strategies, PROs, patient inputs, regulatory engagement, literature reviews, questionnaire preparation, trial protocol and analysis review.
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Description
Title: Epidemiologist II
Location: West Point, PA Rahway, NJ (HYBRID)
Duration: 24 months
Shift: 8 AM – 5 PM
Job Description:
Minimum Education Requirement: