Clinical Outcome Assessment Lead
posted by: spj_bot
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
We are seeking a Clinical Outcome Assessment (COA) Lead to drive COA strategy across innovative clinical development programs, ensuring the patient voice is integrated into clinical research and that meaningful outcomes are used to demonstrate the real impact of treatments on patients' lives.
Key Responsibilities:
- Define and lead the COA strategy across clinical development programs.
- Ensure the patient perspective is incorporated into study design and endpoint selection.
- Select, develop, and validate appropriate COA instruments (PROs, ClinROs, ObsROs, PerfOs).
- Provide scientific expertise on patient-centered outcomes and endpoint strategy.
- Collaborate cross-functionally with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.
- Support regulatory submissions, publications, and scientific communications related to COA data.
- Oversee COA implementation and data quality throughout clinical studies.
Requirements