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    Senior Clinical Scientist/Medical Monitor - Cardio - Home Based (Us Or Canada)

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    7+ years
    Not Disclosed
    Remote, USA
    10 Nov. 8, 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, CPC Certified, 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 Opportunity: Senior Clinical Scientist | ICON plc (Remote, US/Canada)

    About ICON
    ICON plc is a leading global healthcare intelligence and clinical research organization dedicated to helping clients accelerate the development of drugs, biologics, and medical devices. We are currently seeking a Senior Clinical Scientist (Sr. CS) to join our team in this exciting remote opportunity.

    Role Overview

    As a Senior Clinical Scientist at ICON, you will play a critical role in the design and execution of clinical studies, ensuring scientific rigor in every phase. You will serve as the clinical point of contact for internal and external stakeholders, overseeing the medical monitoring process, protocol development, and data analysis. This role is ideal for someone with a strong background in clinical research, medical monitoring, and therapeutic expertise.

    Key Responsibilities

    Study Leadership & Clinical Execution

    • Lead or support clinical studies, ensuring adherence to protocol and scientific integrity.
    • Responsible for trial design, endpoint development, and overall clinical/scientific execution, in collaboration with the Clinical Development team.
    • Act as the clinical point of contact for internal and external stakeholders, including sites and IRBs, addressing scientific issues and questions.
    • Oversee the Medical Monitoring (MM) team and develop the Medical Monitoring Plan (MMP).
    • Coordinate with medical writing to prepare clinical trial study reports (CTRs), clinical trial documents (CTDs), and publications.
    • Collaborate with stakeholders to prepare protocol amendments, clarify protocols, and update informed consent forms.

    Data & Safety Management

    • Review safety data, including SAE reports, and ensure timely resolution of clinical issues.
    • Monitor central lab reports and external data for safety concerns and critical values.
    • Participate in the planning of lab specifications and bio-specimens, as well as image specifications.
    • Contribute to the preparation and reconciliation of protocol deviation reports and assist with CSR preparation.

    Scientific Support & Mentorship

    • Act as the scientific lead on Clinical Trial Teams (CTT), collaborating across disciplines and ensuring all deliverables are met.
    • Provide scientific expertise to data management, statistical teams, and medical writing to guide clinical deliverables.
    • Mentor junior clinical scientists and support their professional development.
    • Prepare and present protocol information at Investigator Meetings and represent ICON in external collaborations.

    Collaboration & Communication

    • Coordinate planning for randomization and allocation requests, along with other logistics.
    • Provide scientific input for operational reviews and communicate clinical results to stakeholders.
    • Co-author newsletters, publications, and conference materials to disseminate study results.

    What You Need

    • Education:

      • BS/BA in Life Sciences with 7+ years of clinical research experience OR
      • MS/PhD in Life Sciences with 5+ years of clinical research experience.
      • If no degree in Life Sciences, at least 11 years of clinical development experience.

    • Experience:

      • Minimum 2 years as a Lead Clinical Scientist with pharmaceutical or clinical drug development experience.
      • Medical monitoring experience is required, with a preference for cardiovascular experience (e.g., atherosclerosis).
      • Proficiency in Excel and PowerPoint.
      • Excellent written and oral communication skills.
      • Ability to travel up to 15%, including potential international travel.

    • Authorization:

      • Applicants must be legally authorized to work in the US or Canada and not require sponsorship for employment visa status.

    What ICON Offers

    ICON is committed to supporting the well-being and development of its employees. In addition to a competitive salary, we offer a range of benefits designed to promote work-life balance, health, and personal growth.

    • Annual Leave: Generous vacation entitlements.
    • Health Insurance: A range of plans to suit you and your family's needs.
    • Retirement Planning: Competitive retirement savings options.
    • Employee Assistance: Global 24-hour access to a network of health and well-being professionals.
    • Additional Benefits: Childcare vouchers, gym memberships, travel subsidies, and more.

    Why ICON?

    At ICON, we prioritize diversity, inclusion, and fostering an environment where talented individuals can thrive. We are proud of our diverse workforce and the work we’ve done to become a more inclusive organization.

    ICON is an equal opportunity employer, offering equal employment consideration to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Interested? Apply Today!

    If you have the qualifications and experience to lead clinical studies in a global healthcare organization, apply now. Even if you are unsure about meeting all of the requirements, we encourage you to apply – you might just be what we’re looking for!

    🔗 Apply Now

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