Clinical Scientist

Job Tittle: Clinical Scientist
Location: RARITAN / NJ / 08869
Duration: 04 Months
Pay Range: $(60.00 - 61.51)/hr on W2

Job Description:
Summary:

• This role is responsible for translating and implementing non-medical scientific concepts into the design, execution, and reporting of clinical programs and studies.
• Key responsibilities include overseeing the integration of biomarkers, digital technologies, and data science initiatives, ensuring the successful operational implementation of these aspects.
• The position involves providing scientific expertise, contributing to clinical development plans, preparing study protocols and training materials, and participating in key review meetings.
• The role also includes collaborating with cross-functional teams, such as Data Sciences, Data Management, and Clinical Leaders, to ensure high-quality study execution, data integrity, and effective communication with clinical investigators.

• 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, JJIT 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.

• A minimum of a Bachelor's degree is required.
• 3 years of experience with medical and safety reviews.