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    Associate Director, Clinical Trial Management - New York, United States - i-Pharm

    i-Pharm
    i-Pharm New York, United States

    13 hours ago

    Default job background
    Pharmaceutical / Bio-tech
    Description
    The base salary range for this position is $170,000 - $190,000.

    What you will be Doing

    Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
    • Coordinate site management activities:
    • Site identification, recruitment, and selection.
    • Regulatory document collection and review.
    • Overall scheduling and management of all site visits.
    • Develop site/monitoring tools and training materials.
    • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
    • Coordinate and oversee daily operations of clinical monitoring team:
    • Set and enforce project timelines with the assigned study team.
    • Coordinate remote review of clinical data within EDC system.
    • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
    • Review and approve trip reports and follow-up letters within required timeframe.
    • Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
    • Manage project milestones and proactively address deficiencies
    Manage CRA performance:
    • Define and implement functional standards, goals, and expectations with clinical monitoring team.
    • Serve as CRA mentor and perform accompanied field assessment visits as required.
    • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
    • Documentation Duties/Responsibilities:
    • Assure that the appropriate SOPs are followed.
    • Ensure all project documentation is appropriately filed per SOPs.
    • Assist PM in preparation of audit responses, as appropriate.
    Required Experience
    • Thorough knowledge of clinical research process.
    • Strong communication skills (verbal and written) to express complex ideas.
    • Excellent organizational and interpersonal skills.
    • Ability to manage multiple priorities within various clinical trials.
    • Ability to reason independently and recommend specific solutions in clinical settings.
    • Understanding of basic data processing functions, including electronic data capture.
    • Working knowledge of current ICH GCP guidelines and applicable regulations.
    • Ability to work independently, prioritize and work with a matrix team environment is essential.
    • Prior experience in electronic data capture (EDC) preferred.
    • Able to mentor CRAs and more junior Clinical Trial Managers.
    • BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
    • Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
    • Minimum of 5 years as a successful Lead CRA or Clinical Trial Manager.
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