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PSI CRO · 7 hours ago

Sr. Clinical Trial Specialist

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

PSI CRO is a leading Contract Research Organization with over 30 years in the industry, focusing on delivering quality and on-time services across various therapeutic indications. The Sr. Clinical Trial Specialist is responsible for leading research efforts for new business opportunities and data analytic strategies within the feasibility department.

Business Information SystemsHealth CarePharmaceutical

Culture & Values

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

Qualification

Clinical research experienceProtocolsICH GCPLife sciences degreeData analytic strategiesTraining skills

Required

University/college degree in life sciences

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

Preferred

Advanced degree in life/biomedical sciences

Company

PSI CRO

Glassdoor4.1

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

Founded in 1995

Zug, Zug, CHE

1001-5000 employees