Clinical Outcome Assessment Lead
E
ExcelyaClinical research
France. United Kingdom. GreeceFull-TimeLead
Salary not disclosed
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Job Details
- Required Skills
- Project ManagementStakeholder management
Requirements
- Hold an advanced degree in Life Sciences, Psychology, Public Health, Epidemiology, or a related field.
- Have proven experience in a COA role within the pharmaceutical or biotechnology industry.
- Have a strong understanding of patient-focused drug development and outcome measurement.
- Have knowledge of qualitative and quantitative research methodologies.
- Be familiar with global regulatory expectations regarding patient-centered endpoints.
- Bring project management, stakeholder management, and communication skills.
- Be comfortable working in a global, cross-functional environment.
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, including PROs, ClinROs, ObsROs, and PerfOs.
- Provide scientific expertise on patient-centered outcomes and endpoint strategy.
- Collaborate 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.
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