Sr. Clinical Trial Specialist
PSI CRO
1d
About The Position
The Sr. Clinical Trial Specialist works within the feasibility department in leading research efforts for new business opportunities and data analytic strategies.
Requirements
- University/college degree in life sciences. Advanced degree in life/biomedical sciences is preferred.
- Minimum 3 years of prior experience in clinical research/medical or scientific research or equivalent.
- Excellent knowledge of reviewing and understanding protocols, ICH GCP, local laws and applicable regulations in the region.
Responsibilities
- Assesses key study elements that impact investigator interest and patient enrollment
- Reviews scientific literature, industry benchmarking, competition and treatment landscape, epidemiology, PSI historical data, and standards of care
- Develops blinded feasibility questionnaire based on key enrollment drivers and manages the outreach process
- Develops protocol-specific questions for PSI Scientific Advisory Board review
- Completes protocol comparison
- Builds country ranking tables based on key study criteria
- Models enrollment scenarios for dose escalation and expansion studies within PSI Study Modeling tool, VISIONAL
- Develops slides for Bid Defense Meetings (BDM)
- Leads data analytic strategies and integration with CTMS/Site Identification Module
- Supports local country site outreach efforts for new business opportunities and awarded studies
- Conducts trainings of PSI staff
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
