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Precision for Medicine is seeking a Principal Clinical Scientist to work remotely. The Principal Clinical Scientist will manage the operational clinical science function from study start-up through database lock for assigned projects. They will focus on scientific and indication-specific insights into data collection and data visualization outputs to support scientific, clinical-sense data cleaning. The role involves serving as the subject matter expert in the application of clinical knowledge, guidelines, and standards of care to the review of clinical trial data.Responsibilities:
  • Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s).
  • Serve as a resource for project teams regarding scientific-related data capture, review & cleaning.
  • Support & participate in the development & implementation of process flow for integrated, cross-functional, data cleaning.
  • Manage Medical Monitor review of subject data.
  • Provide protocol review from a scientific operational perspective.
  • Provide indication-focused, scientific, clinical input & support to Data Management.
  • Oversee &/or develop & maintain CSAI project related plans, guidelines, & trackers.
  • Support &/or conduct holistic &/or aggregate scientific, clinical sense data review.
Requirements:
  • Bachelor’s degree or equivalent in science or health-related discipline.
  • Minimum of 8 years of clinical research experience.
  • Minimum of 1 year of leadership experience.
  • Oncology therapeutic experience.
  • Experience in trial phase I, II and III.
  • On-site monitoring experience and/or data review experience.
  • Experience with electronic data capture systems (EDC) and data visualization tools.
  • Computer proficiency.
  • Professional use of the English language; both written & oral.
  • Working knowledge of FDA & ICH/GCP regulations and guidelines.
  • Ability to occasionally travel domestically & internationally.
The role with Precision for Medicine offers:
  • Remote Work
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Precision Medicine Group

Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.