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  • Posted: Oct 18, 2022
    Deadline: Not specified
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    IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to ...
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    Senior Clinical Research Associate

    JOB DESCRIPTION

    • IQVIA is looking for various Senior Clinical Research Associates in Ghana, Senegal, Nigeria and Ivory Coast to work on new excising opportunities.
    • Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

    Essential Functions

    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
    • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
    • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
    • Collaborate and liaise with study team members for project execution support as appropriate.
    • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
    • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

    Qualifications

    • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
    • Requires at least 2 years of year of on-site monitoring experience.
    • Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
    • i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Good therapeutic and protocol knowledge as provided in company training.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
    • Written and verbal communication skills including good command of English language.
    • Organizational and problem-solving skills.
    • Effective time and financial management skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

    go to method of application »

    Statistical Programmer 2 - Real World Evidence

    Job Overview:

    • As a Statistical Programmer 2, you will provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs.
    • You will plan and lead the development of project-related solutions to the full scope of statistical programming tasks.
    • As a lead programmer on assigned studies, you will write and maintain programming specifications datasets and program TLFs, to maximize programming efficiency with the use of biostatistical tools and assist in training and mentoring new or junior team members

    Essential Candidate Requirements:

    • Bachelors or Masters’ in Computer Science, Mathematics or equivalent
    • 3+ years, statistical programming experience within the Life Science industry in SAS
    • Experience as project lead, directly engaging clients and coordinating tasks within a programming team
    • Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
    • Ability to independently lead multiple tasks and projects
    • Already possess the right to work in the UK or EMEA. We cannot offer visas, work permits or support with new EU Blue Cards for this role

    Method of Application

    Use the link(s) below to apply on company website.

     

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