Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Overview Axle is seeking a highly ambitious, adaptable, structured, and detail-orientedScientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), Office of the Director (OD). Responsibilities
Gain and maintain a comprehensive understanding to ACTIV3 protocol and, as requested, other COVID-19 protocols
Identify and obtain resources needed to establish and maintain DCR’s International Coordinating Center as high-functioning and capable of meeting and exceeding the INSIGHT requirements for its ICCs
Provide senior level oversight of the work of the DCR ICC team including setting deadlines. Identify and resolve barriers to task completion.
Provide assistance and guidance to executive level management
Provide recommendations to DCR leadership for decisions / actions related to the DCR ICC
Assist with the development and implementation of ICC operational framework including processes,
leveraging existing INSIGHT ICC procedures and processes whenever possible and appropriate.
Assist with the development and implementation of the strategy for coordination of clinical trial
operations in concordance with NIAID DCR leadership.
Ensure adequate resources are available for the following areas of trial management:
Safety
Monitoring
Training
Pharmacy
Laboratory
Human subjects protection
Regulatory adherence
Communications
Support sites that are conducting or are interested in conducting the trial(s) in identifying and
resolving gaps in staffing.
Review enrollment and determine areas of need
Develop strategies to increase enrollment
Develop strategies to optimize site participation and adherence to protocols
Liaise with other agencies and organizations when necessary
Liaise with consultant groups to optimize performance
Support DCR in identifying potential sites for participation in the trial(s)
Participate in engagement with, and addition of, new sites
Develop and implement standard operation procedures for trial implementation
Participate in clinical trial agreement negotiations and discussions with sites and networks
Participate in the Quality Assurance/Quality Control processes
Prepare reports for DCR leadership as requested
Assist with developing budgets and monitoring costs
Experience Required / Requirements
Masters degree in related field or equivalent experience
Minimum of twenty (20) years’ experience in related field
Expertise in management and operations
Expertise in the fundamentals of clinical trials
Experience with IRB and FDA requirements
Experience in clinical research setting with protocols and clinical trials
Excellent writing skills
The position will involve frequent interaction between NIAID Federal and other contract staff,and sites interested in, or engaged in ACTIV3 or other NIAID COVID-19 clinical trials. Interactions include activities that require continuity, a high level of collaborative problem solving, and time-sensitive decision making.
Candidates shall be required to handle proprietary information in the strictest confidence and shall be bound by the same terms as the Government in this respect.
Candidates shall ensure representation in all required conference/video calls as a critical communication platform for all aspects of the program.
Fluent in English; Spanish and other languages are a plus.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate. Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.