Scientific Project Manager
Axle · Rockville, MD
(ID: 2026-3856)
Axle 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 nationally and abroad. 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).
Axle is seeking a Scientific Project Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Additional Qualifications:
Certifications & Licenses
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Ph.D.
Field of Study
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Miscellaneous Biology
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Multi-Disciplinary or General Science
Software
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Graphing and reference and bibliographic software
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MS Office
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SharePoint
Skills
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Medical/scientific computer databases to search and collect information
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Designing and creating documents, using desktop publishing software and office tools
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Data analysis and graphing
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Scientific Writing and Communication
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Project management, website content management
Deliverables:
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Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period - Monthly
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Status reports to assess progress, as requested by the Task Leader - Ad-Hoc
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Meet with lab members to present updates - Monthly
Statement of Work Details:
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Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing. - 1
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Monitor the work of the data analysis and scientific writing team members and provide senior scientific and technical leadership for team activities and deliverables. - 2
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Promote quality and consistency across data analysis and scientific writing team activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement. - 3
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Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints. - 4
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Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research. - 5
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Develops and assists staff implement policies and procedures related to the organization's scientific programs.
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Serve as Team Lead of the VRC CTP Data Analysis and Scientific Writing (DASW) team and provide senior scientific and technical leadership for team activities and deliverables.
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Coordinate and prioritize DASW activities and assignments in alignment with CTP clinical research priorities, study timelines, regulatory and public reporting requirements, and available resources.
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Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints.
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Track team activities and deliverables; identify potential risks, delays, competing priorities, or other issues that may affect timely completion of work; and provide recommendations for resolution or escalation to CTP leadership, as appropriate.
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Serve as a primary DASW point of contact for CTP leadership and other CTP functional teams and participate in CTP Team Leads meetings.
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Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.
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Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in VRC clinical research.
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Provide technical guidance, mentorship, and training to DASW Scientific Advisors and other team members and support onboarding, knowledge transfer, and development of consistent scientific practices across the team.
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Promote quality and consistency across DASW activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement.
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Facilitate resolution of cross-functional scientific or operational issues affecting DASW activities and communicate unresolved or significant issues to appropriate CTP leadership.
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Collects, analyzes and creates scientific program information.
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Review scientific and analytical deliverables prepared by PhD-level DASW Scientific Advisors to promote scientific rigor, accuracy, completeness, consistency, and adherence to applicable requirements.
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Verify that clinical trial objectives and endpoints related to immunogenicity, pharmacokinetics (PK), and other assigned scientific analyses are appropriately addressed in study analyses and reporting.
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Review clinical trial analyses and results to assess whether conclusions are scientifically supported by the available data and are presented accurately and consistently across reports, publications, presentations, and other scientific communications.
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Verify that applicable clinical trial results are prepared and reported in accordance with relevant public reporting requirements and established CTP processes and timelines.
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Support appropriate management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated data management systems in accordance with applicable procedures.
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Review scientific content prepared for peer-reviewed publications, clinical trial result summaries, scientific presentations, posters, and other communications to promote clear, accurate, and appropriately contextualized reporting of VRC clinical trial findings.
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Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing.
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Coordinates workshops and reports their outcomes.
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Serve as Chair of the VRC Scientific Review Committee and coordinate the scientific review of VRC clinical trial protocols in collaboration with committee members and other subject matter experts.
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Facilitate timely completion and documentation of scientific reviews and resolution of scientific comments to support protocol development and review.
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Provide subject-matter expertise in immunology, vaccinology, translational research, and the clinical evaluation of novel vaccines and monoclonal antibodies to CTP leadership, clinicians, scientists, and internal and external collaborators.
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Provide scientific and analytical consultation during clinical research planning and protocol development, including review of study objectives, endpoints, sampling strategies, and approaches for analysis and interpretation of clinical and immunologic data.
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Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and other study-specific documents relevant to clinical trial data generation, analysis, and reporting.
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Collaborate with clinical investigators, stat