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    Clinical Data Svs Specialist

    Accenture
    7-11 years
    Not Disclosed
    Bangalore
    10 Oct. 30, 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 Title: Clinical Data Services Specialist
    Skill Required: Clinical eTMF Management
    Qualifications: Bachelor of Pharmacy/Master of Pharmacy
    Experience: 7 to 11 years

    About Accenture:
    Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song—powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 employees deliver on the promise of technology and human ingenuity every day, serving clients in over 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.

    What You Will Do:
    As a Clinical Data Services Specialist aligned with our Life Sciences R&D vertical, you will be integral to the Clinical Data Management team, which supports the entire lifecycle of clinical trials. Your responsibilities will include:

    • Overseeing the collection, integration, and availability of data to ensure appropriate quality and cost.
    • Conducting data management activities such as discrepancy review, query generation, and resolution.
    • Developing and maintaining CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.
    • Identifying protocol deviations and performing edit check validation through test cases.
    • Writing test scripts and conducting database validation (UAT) against specified CRF/ECRF.
    • Managing clinical data management projects.

    You will utilize strategies, methods, and tools throughout the lifecycle of clinical trial regulated content, including data review and accuracy checks of trial master file table of contents, initial full protocol packages, amended FPP checklists, end-of-trial checklists, essential document reconciliation, and clinical study report appendices.

    What We’re Looking For:
    Ideal candidates will demonstrate:

    • Strong expertise in Clinical eTMF Management.
    • Adaptability and flexibility in dynamic environments.
    • Ability to perform under pressure and strong problem-solving skills.
    • Detail-oriented with a focus on establishing strong client relationships.

    Roles and Responsibilities:

    • Analyze and solve moderately complex problems, potentially creating new solutions by adapting existing methods and procedures.
    • Understand the strategic direction set by senior management as it relates to team goals.
    • Engage primarily with your direct supervisor, with potential interactions with peers and management at clients or within Accenture.
    • Receive guidance on methods and procedures for new assignments.
    • Make decisions that often impact your team and manage small teams or work efforts if in an individual contributor role.

    Please Note: This role may require you to work in rotational shifts.

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