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    • Clinical Operations Study Country Lead - Johannesburg - Clinical Research Training Academy

    Clinical Research Training Academy
    Clinical Research Training Academy Johannesburg

    4 weeks ago

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    Description

    About the Job

    Clinical Operations Study Country Lead (COSCL) oversees country-level operations in clinical studies. This role owns and is accountable for strategic planning, management, and performance of assigned clinical trials at the Clinical Study Unit (CSU) level.

    The COSCL is the key interface with internal and external stakeholders to manage operational processes and accelerate trial conduct.

    • Globally: Clinical Operations Study Lead (COSL), Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment and Retention Lead, and other Core Study Team members.
    • Locally: Clinical Research Associate (CRA), Clinical Project Assistant (CPA), Medical Advisor (MDA), Site Engagement Lead (SEL), Strategic Start Up Manager (SSUM), Medical Science Liaisons (MSL), and other relevant roles.

    Main Responsibilities Include:

    1. Develop and lead country start-up activities: Create early recruitment and retention strategies and materials, identify successful site mapping, and set up site engagement strategies.
    2. Lead local study management: Own local level performance of the study, ensuring compliance with planning and agreed timelines. Manage sites engagement, risk assessment, and mitigation strategies.
    3. Manage study budget: Collaborate on preparation of Local Study Cost Request (LSCR), ensure cost optimization, and timely escalation of issues related to the country budget.
    4. Foster effective communication: Be the main link to the local monitoring team, collaborate with vendors, and coordinate study site engagement activities.
    5. Maintain quality and compliance: Ensure data quality, patients' safety, and compliance to study metrics.

    About You:

    • Bachelor's degree in nursing, biochemistry, or a related natural science. Experience in clinical research is mandatory, preferably combined with project management experience.
    • Solid knowledge of clinical development process and relevant therapeutic/disease area(s).
    • Strong project management skills, problem-solving, and risk-management skills in a clinical study environment.
    • Data analytic skills and use of digital tools, platforms, and systems.
    • Change management skills and interpersonal skills to create trustful relationships with stakeholders.
    • 10% travel (in-country travel).

    Required Behaviors:

    1. Challenge the status quo and prioritize outcomes-driven decisions.
    2. Put the organization's interests ahead of individual goals.
    3. Act in the interest of patients and customers.
    4. Take action and make informed decisions that drive progress.

    Pursue progress, discover extraordinary.

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