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    Clinical Data Associate Trainee

    Novotech
    0-1 years
    Not Disclosed
    India
    10 Sept. 25, 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 Description

    Position: Clinical Data Associate Trainee (CDA-Trainee)
    Department: Data Management
    Location: Novotech

    Brief Position Overview:

    The primary responsibility of the Clinical Data Associate Trainee is to support the Data Management department at Novotech. The CDA-Trainee will engage in data entry, review, coding, and provide administrative support to Clinical Data Managers (CDMs) on clinical trial projects, ensuring compliance with Good Clinical Data Management Practices (GCDMP).

    Minimum Qualifications & Experience:

    • Bachelor's degree in life sciences, pharmacy, clinical research, or a related field. Relevant experience or qualifications in allied professions will also be considered.
    • A solid understanding of clinical research and data management processes is preferred.

    Key Responsibilities:

    • Ensure accurate data acquisition, validation, coding, and reconciliation for clinical studies, maintaining quality according to Novotech standards.
    • Perform data entry of clinical trial data using Clinical Data Management software.
    • Assist CDMs with data cleaning, validation, and reconciliation of external data.
    • Track received and entered CRF pages, as well as data queries sent and received.
    • Coordinate activities related to coding and electronic data transfers, addressing any discrepancies.
    • Support CDMs in database testing and edit check testing as needed.
    • Help create reports, listings, and other outputs required during the project.
    • Participate in project meetings as requested by CDM.
    • Provide general administrative support to the Data Management team based on CDMs' needs.
    • Assist in clinical coding and address related data queries as appropriate.
    • Undertake any additional tasks related to the daily operations of the Data Management team as directed by the Line Manager.

    About Novotech:

    Novotech is committed to fostering an inclusive workplace, prioritizing gender equality and respect for all individuals. We offer flexible working options, paid parental leave for both parents, wellness programs, and ongoing professional development. We welcome applicants from diverse backgrounds, including those identifying as LGBTIQ+, individuals with disabilities, and those with caregiving responsibilities. As a Circle Back Initiative Employer, we commit to responding to every application.

    About Us:

    With offices in 11 regions, Novotech provides comprehensive clinical development services across all trial phases and therapeutic areas, including feasibility assessments, regulatory submissions, data management, statistical analysis, medical monitoring, and project management. Novotech has achieved ISO 27001 certification, ensuring high standards of information security alongside our ISO 9001 Quality Management system.

    About the Team:

    Novotech is a leading Asia-Pacific biotech specialist CRO, operating under two brands: Novotech and PPC. We have successfully managed over 3,700 clinical projects, ranging from Phase I to Phase IV trials and bioequivalence studies. As of September 30, 2021, our team comprises over 2,750 FTEs across Asia-Pacific, the United States, and the UK, positioned to support biopharmaceutical clients conducting clinical trials globally.

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