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    Clinical Scientist

    Source One Technical Solutions
    3-5 years
    Not Disclosed
    Titusville
    10 July 4, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Job Title: Clinical Scientist (Contractor)
    Company: Source One Technical Solutions
    Location: Mercer County, NJ (Hybrid, mostly remote)
    Duration: 6-12 months (with likely extension)
    Hours: 40 hours/week, Mon-Fri
    Note: No sponsorships or C2C

    Job Overview

    Source One Technical Solutions is seeking a Clinical Scientist for a hybrid consulting opportunity with a global pharmaceutical company. This role involves translating and implementing scientific concepts into study design and execution, integrating biomarkers, digital technologies, and data science initiatives.

    Responsibilities

    Program/Trial Planning, Execution, and Reporting

    • Translation of Scientific Concepts: Lead the translation of scientific concepts into program and study design.
    • Scientific Aspects: Identify and implement scientific aspects of the program/study, including integration of biomarkers and data science/digital health initiatives.
    • Biomarkers and Endpoints: Oversee the assessment, selection, and operational implementation of biomarkers, digital endpoints, and imaging.
    • DEI Strategy: Shape and implement compound and program DEI strategy with Clinical Leader.
    • Clinical Development Plans: Provide expert input into clinical development plans.
    • Documentation: Contribute to the preparation of PED, study protocols, and training materials.
    • Committee Meetings: Prepare for and participate in Protocol Review Committee (PRC) and First in Human (FIH) Committee meetings.
    • Literature Review: Review medical and scientific literature.
    • Study Oversight: Ensure high-quality implementation and closure of the study, ensuring data integrity.
    • Operational Plans: Review and sign off on operational plans.
    • HA and EC Responses: Provide scientific input into Health Authority (HA) and Ethics Committee (EC) responses.
    • Liaison Role: Act as a liaison between the company and clinical investigators for scientific guidance.
    • Data Management: Work with Data Sciences, Data Management, Statistics, Programming, and JJIT to ensure data quality.
    • Data Review: Ensure data quality and identify data quality trends.
    • Adjudication Activities: Set up and lead adjudication activities.
    • Data Visualization: Lead data visualization meetings and document decisions.
    • Contracting: Handle contracting with clinical consultants, IDMC members, and KOLs, including payment oversight.
    • Vendor Oversight: Participate in vendor oversight, focusing on data and technology integration in clinical trials.
    • Clinical Study Reports: Contribute to the completion of clinical study reports.
    • Interpretation and Reporting: Assist in the interpretation, reporting, and preparation of research results for health authority submissions.

    Additional Clinical Research Responsibilities

    • Regulatory Strategy: Partner with Regulatory Affairs to develop regulatory strategy and determine health authority reporting requirements.
    • Safety Management: Oversee the setup of medical review tools and participate in data review meetings.
    • External Communication: Contribute to the generation and sharing of scientific data with patients and the scientific community. May act as a company spokesperson for the publication of clinical research findings and present research results at meetings.

    Requirements

    • Degree: Bachelor's Degree in Neuroscience or related field.
    • Experience:
      • 3-5 years of experience as a Clinical Scientist.
      • Experience in pharmaceutical or clinical settings.
      • Experience with planning, execution, and reporting.
      • Experience with data review, study close-out, and data monitoring.
    • Skills:
      • Integration of biomarkers and data science.
      • Strong communication and data visualization skills.
      • Ability to review medical and scientific literature.

    Notes from Hiring Manager

    • Position is primarily remote but may require hybrid work (1 day onsite).
    • Candidate should be in the EST time zone and local to the worksite.
    • Role supports the Clinical Team (Neuroscience), currently conducting an MG study.
    • No lab experience required.

    Top Skills

    • Data review experience
    • Study close-out experience
    • Clinical scientist experience
    • Data monitoring experience

    For more information or to apply, please visit our website or contact us directly.

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