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    Principal Clinical Data Standards Consultant

    Icon
    5+ years
    Not Disclosed
    Bangalore
    10 Oct. 17, 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

    Position: Principal Clinical Data Standards Consultant

    Location: Bangalore, India

    Join ICON plc, a world-leading healthcare intelligence and clinical research organization, where we foster an inclusive environment that drives innovation and excellence. We invite you to be part of our mission to shape the future of clinical development.

    We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team. In this role, you will be instrumental in designing and analyzing clinical trials, interpreting complex medical data, and advancing innovative treatments and therapies.

    Key Responsibilities:

    • Develop tools to implement and ensure compliance with CDISC, Sponsor, and ICON standards.
    • Collaborate with cross-functional teams to define data collection strategies and standards for clinical trials.
    • Create and maintain training and reference materials related to standards topics, including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
    • Manage the development and maintenance of data management processes and tools.
    • Stay updated on industry trends and regulatory changes related to data standards, integrating them into ICON’s practices.

    Your Profile:

    To succeed in this role, you should possess:

    • A Bachelor’s degree in a relevant field (e.g., Life Sciences, Computer Science); advanced degrees are a plus.
    • Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
    • Advanced proficiency in CDISC standards and relevant regulations (e.g., FDA, EMA).
    • Strong analytical and problem-solving skills, with keen attention to detail.
    • Excellent communication and collaboration skills to work effectively in cross-functional teams.

    What We Offer:

    At ICON, the quality of our people drives our success. We prioritize a diverse culture that rewards high performance and nurtures talent.

    In addition to a competitive salary, we offer a comprehensive benefits package designed for your well-being and work-life balance, including:

    • Various annual leave entitlements.
    • Health insurance options tailored for you and your family.
    • Competitive retirement planning offerings.
    • Global Employee Assistance Programme, LifeWorks, providing 24/7 access to a global network of specialized professionals for support.
    • Life assurance.
    • Flexible country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

    Explore more about our benefits on our careers site.

    Diversity and Inclusion:

    ICON is an equal opportunity employer committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need reasonable accommodations during the application process or to perform essential job functions due to a medical condition or disability, please let us know.

    Interested in the Role?

    If you’re excited about this opportunity but unsure if you meet all the requirements, we encourage you to apply anyway. You might be just what we’re looking for at ICON.

    Are you a Current ICON Employee? Please click here to apply.

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