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    Data Acquisition Specialist

    Parexel
    2+ years
    Not Disclosed
    India Remote
    10 Nov. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Role: Non-CRF Data Lead

    As a Non-CRF Data Lead, you will be the primary owner of non-CRF data strategy and delivery, ensuring fit-for-purpose data quality for clinical studies. Your expertise in managing complex data interdependencies, working across multiple platforms, and collaborating with both internal and external stakeholders will be pivotal to the success of study milestones. This role demands strategic thinking, proactive communication, and hands-on management of non-CRF data collection and transfer processes.

    Key Skills and Competencies

    • Data Expertise:

      • Deep understanding of complex interdependencies in non-CRF data.
      • Proficiency in working across multiple platforms and tools.
      • Strong scientific background in medical, biological, lab, imaging, or life sciences disciplines.
      • Curiosity for data, with the ability to learn quickly and think critically.

    • Leadership and Communication:

      • Ability to take ownership of non-CRF data strategy and proactively engage with study teams and vendors.
      • Clear and autonomous communication with internal and external stakeholders.
      • Capable of challenging and influencing study teams to adhere to non-CRF data principles.

    • Risk Management:

      • Skilled in identifying risks, developing mitigation plans, and negotiating contingency plans to address potential delays.

    • Regulatory and Process Knowledge:

      • Understanding of data management conventions, standards, and downstream processes.
      • Familiarity with compliance and GxP requirements, including SOPs and policies.
      • Experience in clinical trials and knowledge of the drug development process.

    Primary Responsibilities

    Non-CRF Data Collection and Management:

    • Lead the collection of non-CRF data throughout study setup, conduct, and close-out phases for multiple studies.
    • Manage IxRS data loaded into eCRFs and other non-CRF datasets, ensuring data quality and timeliness.
    • Collaborate closely with non-CRF vendors and data providers to set up data transfer agreements, negotiate deliverables, and maintain mutual agreements.

    Standards and Conventions:

    • Implement and oversee non-CRF data collection standards, study conventions, and best practices.
    • Proactively identify and contribute to the development of new processes and guidance documents.

    Project Planning and Communication:

    • Develop detailed study-level project plans, including contingency plans, to meet milestones.
    • Represent DSD (Data Strategy Development) in study working groups or sub-teams, ensuring alignment of specifications and processes.
    • Effectively communicate deliverables, progress, and data issues to stakeholders.

    Cross-functional Coordination:

    • Coordinate cross-functional tasks with an understanding of downstream processes and stakeholder needs.
    • Collaborate with data management, biostatistics, statistical programming, and other study team members.

    Qualifications

    Education and Experience:

    • Scientific background with expertise in medical, biological, lab, imaging, or life sciences.
    • Demonstrated experience in clinical trials and data management.

    Skills:

    • Strong analytical and problem-solving abilities.
    • Negotiation skills to drive vendor and stakeholder alignment.
    • Knowledge of compliance and regulatory requirements (GxP, SOPs).

    Why Join Parexel?

    • Innovative Projects: Contribute to data-driven advancements in clinical research.
    • Collaborative Environment: Work with a global team in a supportive and inclusive workplace.
    • Career Growth: Gain exposure to cutting-edge methodologies and tools while developing your career.
    • Flexibility: Enjoy a remote-friendly work environment with work-life balance.

    #LI-REMOTE

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