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Scientific Program Manager - NIH - OPCRO, DAIDS

Company: Regional Recreation Corporation of Wood Buffalo
Location: Bethesda
Posted on: April 3, 2021

Job Description:

Scientific Program Manager - NIH - OPCRO, DAIDS in Bethesda, Maryland - Careers at CAMRIS International - Headquarters Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Welcome page Returning Candidate? Log back in! Scientific Program Manager - NIH - OPCRO, DAIDS Job Locations US-MD-Bethesda # of Openings 1 Category NIAID Type Regular Full-Time Overview CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world.--Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, bio-defense, and clinical research. CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today! We are seeking a Scientific Program Manager (OPCRO) to support the overall functions of the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) for the ACTIV2 clinical trial. Responsibilities

  • Effectively provide support to OPCRO OD, branches, and teams in the conduct of
    sponsor oversight for the ACTIV-2 trial.
  • Proactively manage ACTIV-2 project level operational aspects, including management of
    timelines, action items, resources, and vendors.
  • Provide efficient updates on trial progress to the Office Director with respect to Office
  • related activities, project plans, trial and project timeline management, quality standards,
    and risk mitigation.
  • Ensure effective project plans are in place and operational and work proactively with the
    DAIDS ACTIV-2 team to set priorities in accordance with applicable project plans,
    DAIDS' policies, standard operational procedures (SOPs), ICH/GCP guidelines and
    regulatory requirements.
  • Assist in tracking activities for ACTIV-2 with respect to protocol implementation and
    individual assets/investigational products.
  • Support tracking of manufactured agents related to the trial against facets of OPCRO
    operations.
  • Ensure potential study risks are escalated to the attention of the branch chiefs/team leads
    and the OPCRO Director, when appropriate.
  • Track and follow up to resolution OPCRO ACTIV-2 issues, ensuring they have been
    completed in a timely manner.
  • Monitor the quality of vendor deliverables, escalate quality issues to the appropriate team
    member, and identify opportunities to improve training, execution and quality control
    across the Office with respect to ACTIV-2.
  • Participate in routine OPCRO meetings to discuss ACTIV-2 quality issues, sponsor
    oversight activities, and planning for process improvements.
  • Review and approve vendor responses to quality concerns against raised issues for
    appropriateness, timeliness and accordance with DAIDS policies, SOPs, and regulatory
    requirements. Qualifications
    • All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
    • At least 5 years of relevant of experience years in the field of human subject protection and
      policy development.
    • The education, skills and relevant years of experience required for each support position
      are consistent with those identified as the minimum requirements for the labor categories
      specified in the contract. Options Apply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Need help finding the right job? We can recommend jobs specifically for you!Click here to get started. Application FAQs Software Powered by iCIMS
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Keywords: Regional Recreation Corporation of Wood Buffalo, Bethesda , Scientific Program Manager - NIH - OPCRO, DAIDS, Executive , Bethesda, Maryland

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