Clinical Scientist

Job Details

Job Title: Clinical Scientist

Location: Raritan, NJ 08869

Duration: 4 months contract on w2

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.

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, 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

Qualifications:

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