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  • Posted: Jan 20, 2021
    Deadline: Not specified
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    Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential ...
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    Centralized Monitoring Lead

    Pharma companies may not have the experience and technology to implement risk-based monitoring solutions effectively. Do you want to be part of the solution by joining IQVIA Centralized Monitoring, where we accelerate the benefits of risk based monitoring (RBM), by providing a highly adaptive approach to best meet the sponsor's unique clinical operations requirements? Utilize your relevant clinical research experience (minimum of 5 years), coupled with your B Sc degree in Life Sciences or related field.

    Key Activities:

    • Partner with Clinical Lead or Project Lead on study to ensure quality and on-time site deliverables
    • Oversee project aligned CAS activities
    • Oversee Centralized Monitors
    • Proactively oversee country CRA / CTA study deliverables
    • Act as main point of contact for Investigational Products (IP) and non-IP related issues
    • Oversee system access management and support access related issues
    • Oversee timely ISF virtual binder creation
    • Annotate country / site file review checklists, follow up / provide oversight of action item resolution for site / country level checklists, perform cross checks as per TMF Quality Plan / RMP and oversee compliance of reviews
    • Manage project resources (CRAs/CMs/CTAs/CASs)
    • Perform trend analysis of clinical aspects of the trail
    • Share trends and agree on action plans
    • Review, triage and actions clinical study alerts
    • Monitor Clinical Operation Plan compliance

    What will enable you to be successful as a CML?

    • Familiarizing yourself with the study protocol, study team, study systems, study specific requirements and deliverables.
    • Proactively identifying risk through trending and analysis and taking actions to mitigate risk
    • Applying strong time management, prioritization and communication skills
    • Positive issue resolution

    Required Knowledge, Skills and Abilities

    • In depth knowledge of Clinical Research functions like Monitoring, Project Management and Regulatory.
    • Strong knowledge of the components of the protocol
    • Strong communication and interpersonal skills, including good command of English language
    • Excellent problem-solving skills
    • Good teamwork skills
    • Ability to work under limited direction
    • Basic software and computer skills, including MS Office applications. Familiarity with related systems and software utilized in clinical operations
    • Ability to establish and maintain effective working relationships with co-workers, managers and clients

    Method of Application

    Interested and qualified? Go to IQVIA on iqvia.wd1.myworkdayjobs.com to apply

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