Clinical Advisor
ORAU - Rockville, MD
Employment Type : Full-Time
Overview: ORAU has a job opportunity for a Clinical Advisor. This position will support of the overall functions of the Office for Policy in Clinical Research Operations. The position is 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.Responsibilities:- Oversee DAIDS’ sponsor Clinical Data Management activities and project timelines on multiple complex interventional clinical trials networks operating in a global setting.
- Oversee technical service providers performing core data management functions including but not limited to CRF/edit check development, user acceptance testing, data cleaning, listings review, data freeze, and database lock procedures.
- Responsible for the oversight of clinical data management deliverables.
- Evaluate and mitigate clinical data management-related 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.
- Apply expert knowledge of regulations governing interventional clinical trials data collection, processing, and systems as evidenced by: proficiency in CFR 21 Part 11, GAMP5, ICH E6 R2, ISO, and any additional regulatory requirements and guidance for data management and electronic information systems for clinical trials, CDISC requirements, ICH Good Clinical Practice (GCP), and Good Clinical Data Management Practices (GCDMP) into routine oversight functions.
- Utilize expert technical knowledge and experience in developing and overseeing systemsdevelopment approaches and systems integrations for complex global interventional clinical trials data management requirements.
- Lead and participate in cross-functional data management-related process initiatives or working groups on behalf of the Division of AIDS.
- Perform project management of multiple ongoing data management activities.
- Responsible for overseeing the end-to-end clinical data management-related activitiesand is the ultimate accountable person for the data management deliverables in terms of quality and delivery according to plan.
- Provide technical leadership for and oversight of clinical data management activities, including:
a) implementation of data management aspects of clinical protocols and data collection systems;
b) strategic input into proposal or protocol design focused on data management considerations;
c) mitigation of potential data management issues by reviewing protocols or other documents for cross-project consistency and identifying standard case report form modules to meet objectives;
d) reviewing data management activities and recommending process improvements; and,
e) maintaining high-level oversight on data quality metrics and data management deliverablesQualifications:- Master’s degree in a related field is required.
- Minimum of 15 years of relevant experienceecific Qualifications
Proof of a COVID vaccination per the Safer Federal Workforce Task Force Guidance for Federal Contractors.