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    Senior Clinical System Designer

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    2+ 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: Senior Clinical System Designer
    Location: Bengaluru/Chennai (Hybrid)

    ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

    Key Responsibilities:

    • Exemplify ICON's values focused on People, Clients, and Performance.
    • Embrace and contribute to a culture of process improvement, streamlining operations to add value and meet client needs.
    • Travel: Approximately 15% domestic and/or international.

    CDMS Responsibilities:

    • Lead study-specific database design within various CDMS systems (Oracle RDC, Medidata Rave, etc.), managing programming activities on multiple complex studies.
    • Review database specification documents created by study teams.
    • Build clinical study database CRF screens based on provided specifications.
    • Create and program edit checks, special actions/functions, and custom programs as per Data Validation Specifications (DVS).
    • Manage timelines for edit check processes and ensure timely resolution of issues.
    • Configure study-specific data interfaces (e.g., IVRS, labs, CTMS).
    • Coordinate CDMS activities on clinical database programming projects, addressing project management issues and balancing multiple assignments.
    • Troubleshoot study building and system integration issues, providing solutions as needed.
    • Participate in study team meetings as an ad hoc member, advising on data collection and delivery tools.
    • Maintain high-quality deliverables through senior review processes.

    CDS Responsibilities:

    • Act as the clinical data delivery lead on multiple programming setups.
    • Review data transformation and programming specifications.
    • Quality assure programming outputs and support validation activities.
    • Manage timelines for programming setup and ensure timely issue resolution.
    • Coordinate study database updates and perform impact analyses for changes.
    • Engage in innovative clinical data delivery discussions as part of project teams.
    • Ensure timely responses to clinical data delivery queries, routing unresolved issues to appropriate SMEs.
    • Contribute to training materials and assist with training course delivery.

    What ICON Can Offer You:

    Our success relies on the quality of our people, which is why we prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers:

    • Various annual leave entitlements.
    • Comprehensive health insurance options for you and your family.
    • Competitive retirement planning to maximize savings.
    • Global Employee Assistance Program, providing 24/7 access to support.
    • Life assurance.
    • Flexible benefits tailored to your needs, including childcare vouchers, gym memberships, and more.

    Commitment to Diversity and Inclusion:

    ICON is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require reasonable accommodation during the application process, please let us know.

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