Scientific Program Manager

Overview

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-oriented Scientific 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: 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.