ORAU has a contingent job opportunity for a Clinical Advisor in support of the overall functions of the Office for Policy in Clinical Research Operations, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), located in Rockville, 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.
- Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs.
- Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
- Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs on behalf of the Division of AIDS.
- Conduct data reviews.
- Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.
- Lead and participate in cross-functional data management-related process initiatives on behalf of the Division of AIDS.
- Responsible for overseeing the end to end data management study related activities on a day to day basis, and is the ultimate accountable person for the data management study deliverables in terms of quality and delivery according to plan.
- Provide oversight for data management activities, including:
- implementation of data management aspects of clinical protocols and data collection systems;
- strategic input into proposal or protocol design focused on data management considerations;
- mitigation of potential data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives;
- reviewing data management activities and recommending process improvements; and
- maintaining high-level oversight on data quality metrics and data management deliverables.