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  • Posted: Jan 23, 2024
    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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    Global Project Leadership - Internship (South Africa)

    JOB DESCRIPTION

    Our Project Leadership Interns are an integral part of our global team and work in partnership with Project Management Analysts and Project Leaders in one of our therapeutic areas including Internal Medicine, Central Nervous System, Gastroenterology, Immunology & Women’s Heath, Cardiovascular Renal Metabolic, Early Phase Oncology and Late Phase Oncology. 

    Your key purpose will be to support with project management activities to mitigate risk, control cost, manage project schedule, and ensure patient safety, data integrity and customer satisfaction on all projects. 

    Essential Functions 

    • Working with Project Management Analysts to provide Project Leaders with accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making 
    • Prepare correspondence, project status reports and presentation materials for project team and customer meetings 
    • Taking and preparing global Project team meeting minutes 
    • Support on the coordination of project schedules 
    • Support the risk and issue management process 
    • Support on relevant sections of Project Management Plans 
    • Support on project resource allocation. 
    • Manage project specific eTraining and oversee compliance. 
    • Introduced to and to support the management of the Project Finances including Estimate at Completion (EAC), monthly expenses, invoices, and reconciliation 
    • Introduction to project vendor management processs 
    • Gain an understanding and support on the maintenance of project baseline and change control processes 
    • Gain an understanding of managing performance dashboards 
    • Supporting Project Management Analyst (PMA) and Project Leader (PL) on file reviews and support audits, as needed. 
    • Drive electronic Trial Master File (eTMF) filing compliance focusing on completeness, timeliness, and quality 

    Qualifications and Experience Required 

    • Completed Bachelor's, Master’s or PhD degree; preference given to Life Sciences, 
    • Project Management, Data Analytics, Systems Engineering and Finance or relevant education or training 
    • good software and computer skills, including Microsoft Office applications, including but 
    • not limited to, Microsoft Word, Excel, and PowerPoint. 
    • An interest in life sciences, clinical research and/or patient health 
    • An interest in Project Management 
    • Analytical/financial/numeracy skills 
    • Strong written and verbal communication skills including good command of English 
    • language to function within a professional work environment. 
    • Evidence of effective problem – solving, analytical and critical thinking skills. 

    go to method of application »

    Centralized Monitor, Dutch Speaking

    JOB DESCRIPTION

    Centralized Monitor - Dutch Speaking

    Are you:

    • Someone who understands dynamics of working with the sites?
    • Results driven and detail-oriented?
    • Good at supporting others on problem solving?
    • Good at planning, time management and prioritization?
    • Skilled at software and computer use, that enjoys technology applied to data analysis?
    • Understands clinical trial conduct, and skill in applying applicable clinical research regulatory requirements and relevant local laws, regulations and guidelines?
    • Able to communicate efficiently and work well across cultures and geographies?
    • Can you speak, read and write Dutch?

    What is a Centralized Monitor?

    A Centralized Monitor (CM) is a key skilled and clinically experienced team member of IQVIA Centralized Monitoring Department. A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.

    What are the responsibilities of a CM?   

    As a CM, you will:

    • Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.                          
    • Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
    • May perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
    • May assist in Developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
    • May participate in (study) team meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items
    • Escalate quality issues pertaining to site to respective Centralized Monitoring Lead / Sr. Centralized Monitor.
    • May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.
    • Review any other information as necessary to determine overall readiness of the patient information for next level review.
    • Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.

    Do you need experience or a degree to apply for this position?

    • You must have a Bachelor's degree in life sciences or related field
    • At least 1 year experience in clinical research field preferred.
    • Fluency in Afrikaans and English is essential.

     

    Method of Application

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