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    Project Lead - Bethesda, MD, United States - Axle

    Axle
    Axle Bethesda, MD, United States

    3 weeks ago

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    Description

    Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe.

    With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries.

    We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

    100% Medical, Dental & Vision Coverage for Employees
    Paid Time Off (Including Holidays)
    Tuition reimbursement and professional development opportunities


    Flexible Spending Accounts:
    Parking Reimbursement Account (PRK)
    Transportation Reimbursement Account (TRN)

    Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Project Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), Office of Clinical Research Affairs (OCRA).

    Provide quality management support for Division clinical research activities.

    Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID – inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities.

    Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.

    Support the development and implementation of the Division's electronic Quality Management System (eQMS).
    Stay current with changes to current industry standards and applicable regulations for quality in clinical research.

    Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management.

    Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.

    Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; Review, track and/or trend routine quality data.

    Report adverse trends to management with proposed remediation plan.

    Based on understanding of Division Operations, look for ways to standardize processes in order to improve quality and/or facilitate efficiency.

    Bachelor's degree in a related discipline.
    Minimum of five (5) years of experience in clinical research or a related field.
    Experience in establishing and managing quality management systems for clinical research for IND sponsors (e.g. in pharmaceutical companies, biotechnology companies, or government sponsors).
    Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes.

    Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.

    Knowledge of electronic clinical quality management systems such as Master Control is preferred.
    Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
    Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
    Ability to produce high-quality work on complex problems with cross-functional involvement.
    Proficient in Window based software to include Excel, Word.
    The diversity of Axle's employees is a tremendous asset.

    We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

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