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    Director Clinical Operations - Boston, United States - Green Key Resources

    Green Key Resources
    Green Key Resources Boston, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Join our team as a Director Clinical Operations where you'll play a pivotal role in orchestrating the planning, execution, and oversight of clinical studies. Your responsibilities include managing day-to-day operations, collaborating with Clinical Research Organizations (CROs), clinical sites, and third-party vendors. Thrive in our dynamic, innovative setting, showcasing your flexibility, proactive approach, resourcefulness, and efficiency. As a mentor, you'll guide junior staff, fostering their growth. Your ability to swiftly analyze complex issues and devise actionable plans is crucial. Additionally, your adeptness in matrix management, communication, attention to detail, and understanding of quality obligations will be indispensable.

    Your Role:

    • Develop and oversee clinical trial project timelines, ensuring clear communication of risks and challenges, and monitoring metrics for accuracy and comprehensiveness.
    • Foster cross-functional collaboration for timely exchange of information and materials supporting clinical trial deliverables.
    • Manage clinical trials from inception to closure, ensuring adherence to timelines and budgets while collaborating across functions.
    • Proactively oversee outsourced partners, identifying risks and ensuring trial deliverables meet performance goals.
    • Cultivate positive relationships with CRO counterparts, promptly addressing site issues and escalating as needed.
    • Collaborate with CROs to maintain current and accurate clinical study databases.
    • Manage scope of work, contract modifications, and budgetary information for clinical trial operations.
    • Ensure operational excellence by overseeing vendors and conducting necessary oversight activities.
    • Perform additional duties as required.

    What You Bring:

    • Bachelor's degree, preferably in nursing, biology, biochemistry, or related field (advanced degree desirable), with a minimum of 10 years' experience in clinical research operations.
    • Minimum of 2 years' oncology experience required, 5 years preferred.
    • Biotechnology experience is advantageous.
    • Early phase experience, including IND submissions, is necessary.
    • Proficient in vendor and project management.
    • Strong written and oral communication skills.
    • Thorough understanding of GCP/ICH and other applicable regulations/guidelines.
    • Excellent organizational and prioritization skills with acute attention to detail.
    • Familiarity with oversight requirements and commitment to quality.
    • Proficiency in MS Office programs such as Outlook, Word, Excel, PowerPoint, and SharePoint.
    • Collaborative spirit for effective teamwork and partnership.
    • Willingness to travel up to 25%.

    Join us and make a significant impact in the field of clinical research

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