Are you a physician with a strong research background in the following areas?
!! Gastroenterology !!
I am collaborating with an Innovate company who manage the entire life cycle of the drug development process primarily within Poland. Multiple workable sites.
The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships
Further Key Responsibilities:
- Directing and overseeing clinical research plans, and providing input to help integrate the Clinical Development Plan with the Drug Development Plan
- Serving as the clinical / medical team expert to provide direction to all project team functions, regularly liaising with KOL’s and organizing Advisory Board Meetings
- Implementing strategies to identify, monitor and resolve clinical / program trial issues
- Reviewing / monitoring safety study data and providing clinical expertise and content to regulatory documents
- Proactively and independently find solutions and drive innovation
- Educated to Medical Degree
- Board Certification / specialist training required Gastro or relative)
- Demonstrable experience in Phase I-III clinical trial management
- Investigator experience
- Ability to influence others; self-starter with an inquisitive nature and practical approach to problem solving
- Demonstrated competence as Study Director / Medical Monitor / Research Physician / Medical Advisor and prior experience working with the FDA or EMEA on responses to inquiries for study related information is not required but is preferred