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    Clin Data Coord

    Iqvia
    1-2 years
    Not Disclosed
    Kochi
    10 July 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, 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 Type: Full-Time

    Job Overview: We are seeking a skilled and detail-oriented Data Manager to oversee the delivery of data management services for single or multi-service projects. The ideal candidate will ensure quality deliverables on time and within budget, providing comprehensive expertise to the Clinical Data Management (CDM) team. This role involves leading the project team, managing communications, financials, and milestone deliverables, and ensuring compliance with Good Clinical Practices (GCPs) and other regulatory guidelines.

    Essential Functions:

    Client Management:

    • Serve as the primary point of contact for customers regarding data management deliverables.
    • Provide project management expertise, including managing continuous process improvements, issue escalation, workload projections, and technical expertise.
    • Engage in direct negotiations with customers, focusing on timelines, financials, processes, and resources.
    • Maintain strong customer relationships and ensure open communication with both the customer and IQVIA management.

    Service Management:

    • Meet regularly with the Data Operations Coordinator (DOC) and/or Data Operations team members to ensure milestones and quality deliverables are met.
    • Establish strong communication channels with the Data Operations team, functional leads, project managers, and other stakeholders.
    • Support DM service delivery by providing comprehensive DM process and technical expertise.
    • Serve as the escalation point for unresolved data issues and collaborate with client data managers, vendors, and internal team members for resolution.
    • Ensure appropriate resources are assigned to meet project deliverables and maintain service performance tracking.
    • Implement proactive quality management plans and identify service and quality issues for resolution.
    • Maintain internal tracking databases and systems.

    Financial Management/Business Development Support:

    • Ensure service and quality meet the agreed timelines and deliverables in the contract/Scope of Work (SOW).
    • Manage the SOW/budget, review financial reports, and participate in project reviews.
    • Identify out-of-scope tasks and manage change orders.
    • Support the RFP process, including reviewing RFP documents, pricing, and attending bid defenses.

    Other Responsibilities:

    • Contribute to DM process improvements or project solutions.
    • Participate in the development and implementation of new technology or tools.
    • Join focus teams or best practice teams, globally or locally.
    • Perform other duties as directed by functional managers.

    Qualifications:

    • Bachelor's Degree or educational equivalent in health, clinical, biological, mathematical sciences, or a related field.
    • 1-2 years of direct Data Management experience, including a minimum of 6 months as a CDM project lead.
    • Proven competence in managing study delivery through the full DM life-cycle, including at least one medium Phase III study.
    • Strong data management skills and thorough knowledge of DM processes, including SAE reconciliation, external data vendor reconciliation, and local laboratory data management.
    • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.
    • Familiarity with Good Clinical Practices and applicable regulatory guidelines.
    • Excellent communication, interpersonal, customer service, and teamwork skills.
    • Strong organizational, problem-solving, and project management skills.
    • Ability to work independently, using available resources such as functional managers and senior DTLs.
    • Comprehensive understanding of the clinical drug development process.

    Location: Kochi, India

    About IQVIA: IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We aim to push the boundaries of human science and data science to make a significant impact—helping our customers create a healthier world.

    Learn more at IQVIA Careers

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