Demo

Clinical Scientist

Source One Technical Solutions
Raritan, NJ Contractor
POSTED ON 3/14/2025
AVAILABLE BEFORE 4/12/2025

W2 only (No 3rd parties)


Top Skills: Medical Review, Safety Review.


  • Responsible for the translation and implementation of (non-medical) scientific concepts into the study design and/or program across planning, execution, and reporting, including integration of biomarkers, digital technologies, data science initiatives, and select vendors Job Responsibilities Program/Trial Planning, Execution and Reporting
  • Responsible for leading the translation of scientific concepts into program and study design
  • Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution and reporting, including (but not limited to) integration of Biomarkers and Data Science/Digital Health initiatives into studies.
  • Oversees the assessment, selection and operational implementation for biomarkers, digital and other endpoints (scales), imaging
  • Accountable for shaping and implementing compound and program DEI strategy together with Clinical Leader
  • Provides expert input in clinical development plans
  • Contributes to the preparation of PED, study protocols and training materials for clinical studies.
  • Prepares for and participates in Protocol review Committee (PRC) and First in Human (FIH) Committee meetings
  • Reviews medical and scientific literature
  • Along with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrity
  • Responsible for the TA review and sign off on various operational plans
  • Responsible for scientific input into HA and EC responses.
  • In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects
  • Works closely with Data Sciences, Data Management, Statistics, Programming, IT and others to ensure data are received in the manner needed to support trial outcomes
  • Responsible for the review of the data to ensure quality and to identify data quality trends.
  • Sets up and leads Adjudication Activities
  • Leads data visualization (DV) meetings and ensures decisions are documented

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