Sr. Clinical Trial Specialist

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

The Sr. Clinical Trial Specialist works within the feasibility department in leading research efforts for new business opportunities and data analytic strategies.

•  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

Qualifications

• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.