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    Scientific Program Manager - Bethesda, United States - CAMRIS International

    CAMRIS International
    CAMRIS International Bethesda, United States

    3 weeks ago

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    Description
    Overview


    We are seeking a Scientific Program Manager to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD.

    Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world.

    Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member.

    Take the next big step in your career and apply below to help us make a difference.

    CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services.

    We combine our proven systems with today's most effective, evidence-based best practices.


    Our core practice areas include:

    clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

    Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
    Responsibilities

    Provide accountability for the scientific deliverables and contributions of the Vaccine Research Center's (VRC) Translational Science Team.

    Oversee essential team functions, ensuring that: All scientific objectives of VRC clinical trials are met; Clinical trial data is accurately analyzed and project timelines established by VRC leadership are met.

    VRC clinical trial data is managed according to best practices and securely archived in digital data management platforms.

    Clinical trial data is accurately communicated in a timely fashion to the public, VRC leadership and internal teams, and external stakeholders including academia, government and industry partners.

    Serve as the Scientific Review Chair in the development of VRC clinical trial protocols to provide subject matter expertise and scientific oversight.

    Perform complex data analysis on first in-human clinical trial data, involving multiple procedures and a variety of technical approaches, including statistical and multivariant modeling.

    Process, analyze and interpret large, complex primary clinical trial datasets.
    Develop novel methodologies for analyzing immunological and pharmacokinetic data from both vaccine and monoclonal antibody clinical trials.

    Develop protocol scientific objectives and analytical laboratory testing plans for first-in-human clinical trials testing vaccines and therapeutics for infectious diseases.

    Prepare high level executive summaries of data for senior leadership to use in key decision making.
    Prepare complex scientific reports for publication in top-tier peer reviewed scientific journals.
    Provide expert advice and consultation related to clinical trials to laboratory and research staff.
    Provide insight to VRC Primary Investigators, scientists, and research staff on clinical and immune assessments assays.

    Author descriptions of complex immune response data and clinical trial results for regulatory reports, product licensees and internal and external stakeholders.

    Provide peer review as a scientific expert for original scientific manuscripts.
    Effectively collect, organize, store, protect, and process data; ensure useability of datasets.

    Lead and manage secure storage of clinical data on digital data management platforms according to industry standards and best practices.

    Provide raw data to collaborators and post to online repositories upon approved requests/as required by NIH data sharing standards.

    Assist FTL with integration of new team members by training junior team members to follow internal work instructions and standard operating procedures (SOPs) pertaining to data analysis and data management.

    Provide guidance related to clinical trials to laboratory staff.

    Participate in planning of new projects; provide expert advice and consultation on development of clinical trial protocols, analytical laboratory testing plans, and statistical analysis plans.

    Write and review technical protocols, work instructions, and reports documenting analytical development studies.
    Qualifications

    Ph.
    D. in Biomedical Science, Biology or a related discipline.
    Minimum of two (2) years of related experience; demonstrates knowledge of a broad range of scientific and technical areas.
    Experience in understanding and analyzing complex biomedical information and research findings.
    Ability to maintain and develop sources of information to gather data and transmit findings in areas of biomedical science.
    Skill in designing and creating documents, using desktop publishing software and office tools.
    Skill in using medical/scientific computer databases to search and collect information.
    Knowledge of graphing and reference and bibliographic software.
    CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at

    . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
    Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

    Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract.

    The background check process may include, but is not limited to the following:
    (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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