Sr. Clinical Trial Specialist

Remote, USA Full-time
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. Apply tot his job
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