Scientific Program Manager

Axtria; Rockville (MD); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a highly ambitious Scientific Program Manager to lead clinical trial operations at a prestigious research institution. This role offers the chance to work closely with top-tier professionals in the biomedical field, driving innovative solutions to advance research. You will be responsible for overseeing trial management, ensuring compliance with regulatory standards, and enhancing site engagement. If you have a passion for clinical research and a proven track record in management, this opportunity will allow you to make a significant impact in the fight against infectious diseases.

Qualifications

• 20+ years of experience in clinical research and operations management.
• Expertise in clinical trials and regulatory requirements.

Responsibilities

• Oversee DCR ICC team and ensure compliance with clinical trial protocols.
• Develop strategies to enhance site participation and enrollment.
• Assist in budget development and monitor costs.

Skills

Management and Operations

Clinical Trials Fundamentals

Excellent Writing Skills

Collaborative Problem Solving

Time-sensitive Decision Making

Fluency in English

Spanish Language Skills

Education

Masters Degree in Related Field

Job description

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).
OverviewAxle 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

1. Gain and maintain a comprehensive understanding to ACTIV3 protocol and, as requested, other COVID-19 protocols.
2. 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.
3. Provide senior level oversight of the work of the DCR ICC team including setting deadlines. Identify and resolve barriers to task completion.
4. Provide assistance and guidance to executive level management.
5. Provide recommendations to DCR leadership for decisions/actions related to the DCR ICC.
6. Assist with the development and implementation of ICC operational framework including processes, leveraging existing INSIGHT ICC procedures and processes whenever possible and appropriate.
7. Assist with the development and implementation of the strategy for coordination of clinical trial operations in concordance with NIAID DCR leadership.
8. Ensure adequate resources are available for the following areas of trial management:
   • Safety
   • Monitoring
   • Training
   • Pharmacy
   • Laboratory
   • Human subjects protection
   • Regulatory adherence
   • Communications
9. Support sites that are conducting or are interested in conducting the trial(s) in identifying and resolving gaps in staffing.
10. Review enrollment and determine areas of need.
11. Develop strategies to increase enrollment.
12. Develop strategies to optimize site participation and adherence to protocols.
13. Liaise with other agencies and organizations when necessary.
14. Liaise with consultant groups to optimize performance.
15. Support DCR in identifying potential sites for participation in the trial(s).
16. Participate in engagement with, and addition of, new sites.
17. Develop and implement standard operation procedures for trial implementation.
18. Participate in clinical trial agreement negotiations and discussions with sites and networks.
19. Participate in the Quality Assurance/Quality Control processes.
20. Prepare reports for DCR leadership as requested.
21. Assist with developing budgets and monitoring costs.

Experience Required / Requirements

1. Masters degree in related field or equivalent experience.
2. Minimum of twenty (20) years’ experience in related field.
3. Expertise in management and operations.
4. Expertise in the fundamentals of clinical trials.
5. Experience with IRB and FDA requirements.
6. Experience in clinical research setting with protocols and clinical trials.
7. Excellent writing skills.
8. 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.
9. 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.
10. Candidates shall ensure representation in all required conference/video calls as a critical communication platform for all aspects of the program.
11. 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