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Scientific Program Manager

Oak Ridge Associated Universities, Bethesda, Maryland

Position Description:

ORAU has a contingent job opportunity for a Scientific Program Manager in support of the overall functions of the Clinical Trials Program, National Institute of Allergy and Infectious Diseases (NIAID), located in Bethesda, MD. The positions are contingent on award of an upcoming contract with NIAID Professional, Scientific and Technical Support Services. Salary for positions will be determined based on education and experience. Relocation support is not available for this position.

ORAU has been providing scientific and technical talent staffing solutions and designing, managing, and evaluating jobs and internships for more than 70 years. ORAU assists in connecting the best and most diverse group of students, recent graduates, faculty and professionals with world-class fellowships, internships and job opportunities, whether in national laboratories, research institutions, federal government offices or private sector R&D departments.

Technical Requirements:
  • Oversee the VRC CTP’s Quality Management System, including leading a Quality Management team of subject matter experts, to ensure quality throughout all stages of the clinical trial process.
  • Ensure staff and program compliance with CTP’s quality procedures and regulatory requirements.
  • Assess GCP compliance risk areas and develop and implement risk mitigation measures, including facilitating Root Cause Analyses (RCAs) and instituting Corrective and Preventive Actions (CAPAs).
  • Provide expertise and guidance on governmental regulations, agency guidelines, and internal policies to assure GCP compliance.
  • Plan and lead GCP sponsor audits of international and domestic clinical sites, contract clinical laboratories, and Contract Research Organizations (CROs) to verify and document compliance status and identify any compliance risks.
  • Conduct Trial Master File (TMF) audits.
  • Facilitate and track GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate as a Subject Matter Expert in the evaluation and selection of CROs and other clinical and nonclinical service providers supporting CTP activities.
  • Develop and implement SOPs, policies and work instructions for GCP regulatory compliance.
  • Identify and seek appropriate resources for the functioning and improvement of the QMS.
  • Work with CTP leadership team and personnel on issues that require resolution or escalation.

Qualifications:

  • All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D.
  • 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.
  • Minimum 5-7 years’ experience in clinical research within Government, Biotech, Pharma and/or CRO and at least 5+ years’ experience in Quality Systems related to GCP. Master’s Degree preferred but not required.
  • Certified quality auditor preferred, but not required.
  • Experience auditing clinical CRO’s, clinical sites and investigator sites.
  • Strong understanding of domestic and international quality and regulatory requirements, regulatory agencies, and ICH/GCP.
  • Outstanding communication skills (interpersonal, verbal and written).
  • Strong leadership skills and experience independently managing complex projects. Experience managing staff or overseeing a team.

To Apply:

You can submit your resume or CV direct to our website at: https://careers-orau.icims.com/jobs/1032/scientific-program-manager/job

Application Deadline Date: December 26, 2020

If you have any questions please email our Lead STEM recruiter at (brian.rose@orau.org

 

The NIH is dedicated to building a diverse community in its training and employment programs.