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Clifton

    Associate Director, Clinical Operations - Clifton, United States - Scientific Search

    Scientific Search
    Scientific Search Clifton, United States

    3 weeks ago

    Default job background
    Description
    Onsite in Clifton, NJ

    What You Can Expect To Be Doing...

    Oversight of US clinical development providing vision, leadership, and mentoring of staff.
    Providing input into clinical trial implementation, execution, and outcome, building consensus within the global clinical operations team.
    Responsible for the day-to-day operations management of clinical trials.
    Management of internal staff and external vendors and contractors.
    Contribute to strategic planning to ensure optimized clinical development plans
    Acquire knowledge of the therapeutic area and products
    Participate directly in all study activities, including protocol review, development of study materials, clinical trial site selection and interaction, contractor and CRO selection and management and safety reporting
    Responsible for departmental resource management, budgets, benchmarking, metrics, performance reviews and establishing standards operating procedures and guidelines
    Regularly interact with upper management in a global setting
    Develop, manage, and adhere to annual departmental budget
    Manage clinical staff (SR. and JR. CRAs, Clinical leaders, Admin, etc.)
    Provide training and mentoring, and ensure fulfillment of responsibilities in accordance with regulations, company policies, and procedures
    Ensure successful execution of projects according to regulatory guidelines, provide technical leadership, and facilitate effective internal and external relationships (e.g., key investigators, opinion leaders, and other industry leaders)
    Provide technical direction in CRO and vendor selection and management
    Conduct performance appraisals as assigned. Provide measurable feedback to managed staff and outlines actions for improved performance. Formulates and implements employee corrective actions as needed
    Working knowledge of data management, data review, analysis, and regulatory submissions
    Assess staffing requirements and fill open positions with qualified candidates
    Provide leadership through effective objective setting, delegation, communication, and role modeling
    Provide technical training and mentorship for the development of clinical documents (protocols, monitoring plans, clinical trail reports, investigator brochures, and trial conduct)
    Manage adverse event review process with medical monitor and drug safety unit to ensure accuracy and completeness
    Participates in development of study protocols, integrated clinical study reports, and IND annual reports
    Take a lead role in presenting data at investigator meetings
    Cooperate in interdisciplinary teams (Corporate Clinical R&D, Regulatory, Medical Affairs) and ensures that timelines are met, conflicts resolved, and projects are kept on time and within budget

    What you will bring to the table....

    BS/BA or higher, preferably in a healthcare or life science discipline
    6+ years of clinical, drug, or biologics development in the pharmaceutical or biotech industry
    Expertise in clinical drug development, operations, and strategic planning, specifically management of clinical trials operations
    Demonstrated experience in managing and mentoring of clinical team members

    If you would like to learn more about this fantastic opportunity, please email

    #IND1

    #J-18808-Ljbffr
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