Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both
inpatient and outpatient settings. Acts as liaison between functions ( PM, investigator, research team, etc.). Ensures client requirements and specifications are communicated to the research teams and any issues / questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.
Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Knowledge of Phase I processes and strong knowledge of clinical study operations
- Knowledge of FDA regulations and ICH GCP guidelines
- Solid computer skills with working knowledge of Microsoft Office applications
- Good time management and multi-tasking skills
- Solid written and verbal communication skills
- Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
- Favorable consulting skills to act as a liaison between external and internal groups
- Knowledge of budgeting / forecasting / planning projects
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