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    • Sr. Specialist, Document - San Diego - Neurocrine Biosciences

    Neurocrine Biosciences
    Neurocrine Biosciences San Diego

    4 weeks ago

    Default job background
    Full time
    Description

    Job Summary:

    We are seeking a highly skilled Clinical Operations Specialist to support our team in creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). The ideal candidate will have a strong background in clinical trial documentation and experience working with electronic TMF systems.

    About the Role:

    This role serves as subject matter expert for eTMF end-users and facilitates responses to audits/inspections. Collaborating closely with Clinical Operations Study Team Members and Functional Groups, you will plan and assist the set-up, review, maintenance, and archival of study specific TMFs according to applicable regulations and industry standards.

    Your Responsibilities:

    • In collaboration with the CO Study Team, Vendors, Functional Group Representatives, and other Stakeholders, plan/assist the set-up, review, maintenance, and archival of study specific TMFs according to applicable regulations and industry standards.
    • Document the set-up, review, maintenance, and archival of study specific TMFs in TMF Plans and study specific TMF Index.
    • Serve as subject matter expert for the eTMF, providing technical expertise and advice to end-users and all stakeholders.
    • Lead monthly eTMF meetings for internal CO Study Team.
    • Administer Clinical System, including managing user access, user training, and system releases.
    • Act as Clinical System Admin, adding organization, user help, troubleshooting errors, etc.
    • Generate and send out monthly dashboards and reports.
    • Informally review key performance indicators related to clinical trial accuracy, timeliness, and completeness of TMFs against milestone-based projections.
    • Proactively inform CO Study Team Leaders and Upper Managers of deficiencies from informal reviews.
    • Prepare for and participate in internal or external audits/inspections, including providing audit/inspection responses and facilitating inspector access to TMFs, as required.
    • Participate in quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary.
    • Support CO Study Team Members in Change Incident Management and Risk Assessment, as requested.
    • Participate in CO Study Team meetings and eTMF QC meetings, as requested.
    • Write/edit TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality, and archival.
    • Demonstrate technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines, and other regulatory requirements.
    • Maintain close working relationships with other functional areas outside of Clinical Operations, such as Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, and Vendors, to facilitate TMF development.
    • Perform other duties as necessary and assigned by management.

    Requirements:

    • Bachelor's or Master's degree in a life science or related field or RN and 4+ years of experience working directly with clinical trial documentation at a biotech/pharmaceutical company or CRO.
    • Able to work independently and function as a team player.
    • Able to manage/prioritize own work.
    • Knowledge of FDA regulations, Good Clinical Practices (GCPs), and ICH Guidelines necessary.
    • Working knowledge of clinical study documents and managing Trial Master Files in Clinical Systems (eTMF and CTMS - Veeva preferred).
    • Ability to process, archive, and retrieve documents in electronic format.
    • Computer proficiency with MS Office.

    We offer:

    • An annual base salary of $108,600-$157,350, depending on primary work location, complexity, and responsibility of role.
    • An annual bonus with a target of 20% of earned base salary.
    • Eligibility to participate in our equity-based long-term incentive program.
    • Benefits, including a retirement savings plan (with company match), paid vacation, holiday, and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, and vision coverage).
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