PSI CRO is hiring a Senior Clinical Trial Specialist to join our feasibility department. In this role, you will lead critical research for new business opportunities and spearhead data analytic strategies that inform study planning and execution.
What You'll Do
- Assess key study elements that impact investigator interest and patient enrollment.
- Review scientific literature, industry benchmarking, competitive landscape, epidemiology, PSI historical data, and standards of care.
- Develop a blinded feasibility questionnaire based on key enrollment drivers and manage the outreach process.
- Create protocol-specific questions for PSI Scientific Advisory Board review.
- Complete protocol comparisons.
- Build country ranking tables based on key study criteria.
- Model enrollment scenarios for dose escalation and expansion studies using the PSI Study Modeling tool, VISIONAL.
- Develop slides for Bid Defense Meetings (BDM).
- Lead data analytic strategies and their integration with the CTMS/Site Identification Module.
- Support local country site outreach efforts for new business opportunities and awarded studies.
- Conduct trainings for PSI staff.
What We're Looking For
- University or college degree in life sciences.
- Minimum of 3 years of prior experience in clinical research, medical, or scientific research, or equivalent.
- Excellent knowledge of reviewing and understanding protocols, ICH GCP, and local laws and applicable regulations in the region.
Nice to Have
- Advanced degree in life or biomedical sciences.
Technical Stack
- PSI Study Modeling tool, VISIONAL
- CTMS/Site Identification Module
Team & Environment
You will work within the feasibility department.
All your information will be kept confidential according to EEO guidelines.
