• Clinical Program Manager

    Posted Date 2 months ago(5/2/2018 7:02 AM)
    Job ID
    2018-2941
    # of Openings
    1
    Job Location(s)
    US-MD-Bethesda
    Category
    Management
  • Overview

    Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

    We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

    Medical Science & Computing is searching for a Clinical Program Manager to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

    Duties and Responsibilities:

    • Serve as the senior advisor to NIH senior management officials for regulatory matters relating to requirements in current Good Clinical Practices (GCP) for clinical research, the Declaration of Helsinki (as applicable), 45 C.F.R. 46, additional Food and Drug Administration (FDA) requirements and other applicable policies and standards to ensure the quality of products used in NIH research, the results obtained in research and the safety and welfare of all clinical research participants.
    • Support development, implementation and maintenance of a training system for FDA regulated activities, identify potential areas of vulnerability and risk within the ICs, support and oversee internal audit and external audit programs, including corresponding corrective action / preventive action (CAPA) and continuous process improvement (CPI) components as appropriate.
    • Serve as senior liaison with the NIH Clinical Center and with the other NIH ICs for compliance and production issues, including facility remediation and project prioritization; manages development of SOPs; interacts with FDA and other oversight officials in these highly-sensitive and critical areas.
    • Design and develop approaches needed to respond to new and emerging departmental and NIH initiatives and mandates in the area of regulatory affairs and compliance for facilities, production, clinical research and cGMP/USP needs.
    • Provide effective leadership in the implementation of management policies and guidelines.
    • Demonstrate extensive knowledge and application of FDA regulated clinical research, laboratory practice, and manufacturing regulations and guidelines, as well as comprehensive knowledge and application of Title 21, Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.
    • Knowledge of current regulatory, safety, and compliance issues and identifies emerging opportunities and challenges.
    • Independent analysis and evaluation of significant problems or questions pertaining to NIH’s research missions, may include outlining alternatives, strategies and options for implementation, and they may become the official response to requests from congressional committees, the Office of the Secretary, and other external sources or may represent major discussion papers on particular aspects of NIH research compliance policy and program development for consideration within the Agency.
    • Provide senior-level staff support to expert committees and major meetings to address facilities and regulatory affairs compliance.
    • Develop short and long range plans to guide the execution of the program within a changing management environment, and evaluates the effectiveness of the program by comparing accomplishments to plans and objectives and by analyzing feedback received from managers and employees.
    • Responsible for special projects of unusual organizational complexity or sensitivity under the direction of the senior management, for both management activities and clinical research workforce and customers.

    Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

    Requirements

    • M.S. degree, Ph.D. preferred, in Life Sciences or related field with at least 5+ years of Clinical Program Management experience.
    • Project Management Professional (PMP) certified with experience in managing clinical projects.
    • Expert knowledge of the regulatory and policy provisions applicable to requirements in current Good Clinical Practices (GCP) for clinical research, the Declaration of Helsinki (as applicable), 45 C.F.R. 46, as well as additional Food and Drug Administration (FDA) requirements and other applicable policies and standards to ensure the quality of products used in NIH research, the results obtained in research and the safety and welfare of all clinical research participants. Must have strong ability to analyze, explain and apply these provisions in a wide variety of settings and with diverse audiences in order to advance the NIH intramural research program.
    • Expert in depth knowledge of the relationship of clinical research investigators, regulatory agencies like the FDA, OHRP, other federal funders, accrediting agencies like the AAAHRPP, and others in the complex network of oversight responsibilities for the conduct of safe and effective clinical research.
    • Knowledge of major regulatory policy issues associated with regulatory affairs for FDA-regulated clinical research to advise the highest level of management on emerging issues.
    • High level of vision, creativity and flexibility to advise the NIH senior management, and others, in the development, coordination, integration and communication of policies which affect the scientific goals and strategies of the NIH.
    • Mastery of planning, analytical, and management principles relevant to research facilities and cGMP/ USP activities and the NIH intramural clinical and pre-clinical research program.
    • Exceptional mastery both orally and in writing sufficient to prepare and present highly complex material, often on conflicting issues, for a broad range of participants including senior level Department and agency officials, scientific community groups, and members of the public.

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