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    Global Program Manager for Clinical Operations - Dortmund, Deutschland - Mantell Associates

    Mantell Associates
    Mantell Associates Dortmund, Deutschland

    vor 4 Tagen

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    Beschreibung

    Mantell Associates are proudly partnered with a leading pharmaceutical company in their search for a Global Program Manager for Clinical Operations to join their senior leadership team. The are seeking an individual who will play a key role in managing and coordinating clinical trials across multiple regions, ensuring the successful execution of the company's global clinical development programs in neurology.

    Global Program Manager for Clinical Operations Responsibilities:

    • Program Management: Lead and oversee the planning, execution, and management of global clinical trials in neurology, ensuring adherence to timelines, budgets, and quality standards
    • Cross-Functional Collaboration: Collaborate closely with cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Commercial to develop and implement strategic clinical development plans
    • Vendor Management: Manage relationships with external vendors, including clinical research organisations (CROs), central laboratories, and other third-party vendors, to ensure successful outsourcing and execution of clinical trials
    • Risk Management: Proactively identify and mitigate risks and issues that may impact the progress of clinical trials, implementing effective risk management strategies to ensure study success
    • Compliance: Ensure compliance with relevant regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal standard operating procedures (SOPs) throughout the conduct of clinical trials
    • Data Management: Oversee data management activities, ensuring accurate and timely collection, analysis, and reporting of clinical trial data
    • Resource Planning: Develop and manage resource plans for clinical trials, including staffing needs, budget allocation, and resource optimisation
    • Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency and effectiveness of clinical trial operations processes
    • Leadership: Provide leadership and guidance to cross-functional teams, fostering a collaborative and high-performance work environment

    Global Program Manager for Clinical Operations Qualifications:

    • Bachelor's degree in life sciences or related field required; advanced degree (e.g., Master's, PhD) preferred
    • Experience in clinical operations management within the pharmaceutical or biotechnology industry, with a focus on neurology preferred
    • Proven track record of successfully managing global clinical trials from start-up through close-out, including experience with Phase II-III trials
    • Strong understanding of clinical trial regulations and guidelines (e.g., ICH-GCP, FDA, EMA) and experience with regulatory submissions
    • Excellent project management skills, with the ability to manage multiple projects simultaneously and prioritise tasks effectively
    • Strong leadership and team management skills, with the ability to motivate and inspire cross-functional teams
    • Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels
    • Fluent in English; additional language skills (e.g., German) preferred but not required

    Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at

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