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    Director Clinical Operations - San Diego, United States - BioPhase

    BioPhase
    BioPhase San Diego, United States

    1 month ago

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    Description
    This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
    Base pay range

    $195,000.00/yr - $215,000.00/yr
    Additional compensation types

    Annual Bonus
    Direct message the job poster from BioPhase
    Clinical Recruiter at BioPhase Solutions

    Hybrid Position | Located in San Diego, CA

    This Director of Clinical Operations will play a pivotal role in leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practices (GCP) as well as in compliance with various governing regulatory agencies.

    This role involves overseeing participating study sites, managing vendors, ensuring compliance with regulatory guidelines, and implementing innovative processes to improve clinical trial management and deliverables.


    Responsibilities:
    Overseeing clinical trial operations and ensuring compliance with GCP guidelines.
    Collaborate with and direct Contract Research Organizations, managing study execution and document development.
    Oversee data review processes, supervise Clinical Research Associates, and support audits of sites and vendors, ensuring efficient trial management.
    Lead and supervise all clinical operations, ensuring adherence to GCP guidelines and regulatory compliance.
    Utilize robust organizational skills and medical writing expertise to manage complex trial activities, including the creation of clear and comprehensive clinical documents
    Utilize project management methodologies to effectively oversee trial execution, ensuring consistent engagement with Contract Research Organizations (CROs) for timely and accurate completion of trial milestones
    Negotiate contracts and manage relationships with vendors and service providers, while partnering with study sites to ensure efficient and professional conduct
    Manage budget negotiations and control expenses to keep trials within financial constraints
    Oversee the site selection process and develop essential study documents and tools, such as protocols, consent forms, project plans, and budgets
    Participate in the creation and refinement of Clinical Operations SOPs and training materials
    Implement and maintain the Trial Master File for inspection readiness and conduct training sessions for study teams
    Provide updates to senior leadership and proactively manage project risks, recommending innovative processes to enhance trial management
    Oversee data integrity through reviews and cleaning activities, and ensure Clinical Research Associates effectively manage site operations
    Support compliance and quality through audits of sites and vendors, manage study supplies, and collaborate with other departments for resource alignment

    Education/Skill:
    Bachelor's or Master's degree in a relevant scientific field
    Minimum of 10 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, or CRO setting: siRNA study experience preferred
    ICH/GCP Training
    Thorough knowledge of drug development, clinical operation processes, and procedures according to ICH/GCP and other regulatory guidelines
    Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint
    Proven ability to manage multiple projects simultaneously in a changing environment
    Proven ability to collaborate effectively with internal teams and external collaborators
    Self-motivated, comfortable working in a start-up environment where everyone contributes to achieving company goals, flexible, and innovative
    Experience managing Phase I - III trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements
    Seniority level

    Seniority level

    Director
    Employment type

    Employment type

    Full-time
    Job function

    Job function

    Other
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