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    Clinical Data Management

    Iqvia
    6+ years
    Preffered by Company
    Hyderabad
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Data Manager

    Job Overview:

    We are seeking a highly experienced Senior Clinical Data Manager to oversee and manage all aspects of clinical data management for our projects. The ideal candidate will have over 6 years of experience in end-to-end clinical data management tasks, from protocol review and CRF design to database lock. This role requires strong expertise in EDC systems, data review, and management, with a focus on ensuring quality and adherence to standard operating procedures.

    Key Responsibilities:

    • Clinical Data Management:

      • Manage all aspects of clinical data management including protocol review, CRF design, and database lock, adhering to organizational SOPs.
      • Develop and implement clinical data management plans and documents, ensuring quality and standardization.
      • Oversee the setup and performance of Clinical Data Management vendors, ensuring timely data review and delivery.

    • EDC Systems & Data Review:

      • Utilize EDC systems such as Medidata RAVE or Oracle Clinical for effective data management.
      • Conduct query trend analysis, protocol deviation review, and reporting.
      • Create and manage study timelines, ensuring deliverables are met as per defined schedules.

    • Documentation & Compliance:

      • Author, review, and revise DM-related study plans, including Data Quality Management Plan, Data Validation Plans, and eCRF Completion Guidelines.
      • Ensure compliance with FDA/ICH guidelines, industry practices, and submission requirements (e.g., NDAs, BLAs, MAAs).

    • Project Management & Leadership:

      • Lead Data Quality Review meetings with cross-functional teams to ensure data currency, quality, and completeness.
      • Represent Data Management on cross-functional project and submission teams.
      • Support Health Authority inspections and audits as required.
      • Provide coaching and quality oversight to the Data Management team.

    • Collaboration & Communication:

      • Collaborate with the Data Management Lead to draft and execute EDC build timelines and specifications.
      • Facilitate startup meetings, including EDC build kick-offs and Interactive Review Meetings (IRMs).
      • Update and maintain study documents and ensure all documents are filed in the eTMF as per the master plan.
      • Communicate effectively with senior management and cross-functional teams, providing updates and addressing issues.

    • Training & Mentoring:

      • Provide training and mentoring to junior CDM staff, fostering their professional development.

    Qualifications:

    • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
    • Over 6 years of experience in clinical data management, including at least 4 years in Pharmacovigilance and 2 years in people management.
    • Extensive experience with EDC systems, particularly Medidata RAVE and Oracle Clinical.
    • In-depth knowledge of clinical drug development processes, FDA/ICH guidelines, and industry standards.
    • Strong analytical skills for data problem resolution and experience with metrics analysis and reporting.
    • Proven ability to work collaboratively on multi-disciplinary project teams and develop effective relationships with external vendors.
    • Excellent oral and written communication skills with the ability to interact effectively with senior management and cross-functional teams.
    • Knowledge of ICH-GCP guidelines, regulatory requirements, and data privacy regulations.
    • CCDM certification is preferred.

    Responsibilities Include:

    • Drafting and executing EDC build timelines in collaboration with the Data Management Lead.
    • Performing database build tasks, creating specifications, and conducting User Acceptance Testing (UAT).
    • Coordinating with Clinical Data Managers and external vendors for data review and issue resolution.
    • Supporting Data Management Lead in project management tasks and ensuring study deliverables meet quality and timeline expectations.
    • Providing Data Health Metrics and performing post-lock activities as needed.

    About IQVIA:

    IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We strive to accelerate the development and commercialization of innovative medical treatments, aiming to improve patient outcomes and global health. To learn more about our opportunities, visit IQVIA Careers.

     

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