What are the responsibilities and job description for the Clinical Scientist position at Source One Technical Solutions?
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
