PSI CRO AG

Senior Clinical Trial Specialist

PSI CRO AG

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

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.
Benefits
  • All your information will be kept confidential according to EEO guidelines.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data analyticsclinical researchprotocol developmentstudy modelingenrollment modelingscientific literature reviewprotocol comparisonfeasibility assessmentbiomedical sciencesdose escalation studies
Soft Skills
leadershipcommunicationtrainingorganizational skillsstrategic thinking
Certifications
ICH GCP