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    Clinical Trial Manager - California, United States - BioPhase

    BioPhase
    BioPhase California, United States

    2 weeks ago

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    Description

    CTM II Hybrid Position | 2/3 Days Onsite Located in San Diego, CA

    Candidates are responsible for managing and overseeing all study-level vendor and site activities related to one or more clinical trials. The ideal candidate should have experience in overseeing Phase I-III trials and possess a solid understanding of clinical operations, GCP, and FDA regulatory requirements.

    Responsibilities

    • Manage all components of clinical trial(s), leading a cross-functional study team under the direction of the disease area lead.
    • Ensure clinical trial activities are completed on time, within budget, and in a dynamic environment while adhering to quality standards such as ICH/GCP requirements and SOPs.
    • Lead the selection and oversight of clinical trial sites, fostering efficient partnerships with Clinical Research Associates (CRA) and study sites for smooth study execution.
    • Develop and implement operational plans to facilitate study enrollment and monitoring activities at clinical sites.
    • Review and track study budget, approve invoices, and ensure Trial Master File compliance for inspections.
    • Provide support in creating project plans, study documents, and lead internal and external meetings for clinical trials.
    • Conduct study data reviews, manage trial-level quality risk, and oversee study supplies.
    • Lead study training sessions and ensure compliance with regulatory inspections and audits.

    Qualifications

    • B.S. degree with a minimum of 7 years of clinical trials management experience in biotech, pharmaceuticals, or CRO settings.
    • Experience in Oncology or autoimmune studies is mandatory, while Immunotherapy or cellular therapy experience is advantageous.
    • Proficiency in clinical operations, global trial conduct, and FDA/ICH guidelines is required.
    • Demonstrated ability to lead project teams, cross-functional study teams, and possess excellent communication and interpersonal skills.
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