Clinical Program Manager

Axle Labs; Rockville (MD); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

Paid time off and holidays

401K match up to 5%

Educational benefits for career growth

Employee referral bonus

Flexible Spending Accounts: Healthcare

Job summary

Axle seeks a Clinical Program Manager to support NIH/NCI in Rockville, MD. The role provides scientific and administrative project management for translational research and clinical trials related to oncology.

Qualifications include clinical trial management experience, leadership, and strong communication. The role offers competitive salary and comprehensive benefits, with a focus on collaboration across CTEP and contracting teams.

Qualifications

• Clinical trial project management experience.
• Previous project management experience and/or clinical trial management including data management.

Responsibilities

• Provide scientific and administrative project management support for NIH/NCI projects.
• Develop a new tracking and reporting system for biomarkers and medical tests funding sources.
• Generate SOPs and workflows for new processes.
• Monitor LOIs and protocols to determine funding mechanisms (CRADA, MoCha, NCLN, grants).
• Collaborate with internal and external stakeholders for IP requirements (CRADAs, MTAs).
• Review, assess and evaluate clinical trial design, feasibility, data, and operations.

Skills

Strong communications

Analytical abilities

Organizational skills

Time management

Clinical trials knowledge

Education

Biology

Tools

Microsoft Office

Job description

Axle

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).

Clinical Program Manager

Axle is seeking a Clinical Program Manager to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Rockville, 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)

Position Information

This position will independently provide support services to satisfy the overall operational objectives of the NCI/DCTD.

Additional Qualifications

Certifications & Licenses

• Clinical trial project management experience.
• Previous project management experience and/or clinical trial management including data management.

Field of Study

• Biology

Software

• Proficiency in using Microsoft software applications (Windows, Word, Excel and PowerPoint).

Skills

• Strong communications skills, both oral and written.
• Excellent analytical, organizational and time management skills.
• Ability to do work assignments and/or projects successfully and completed in a timely manner.
• Ability to work in a busy setting, both independently and within a team.
• Familiarity with area of clinical trials preferably in the field of Oncology

Deliverables

• Work products and documents related to providing scientific and administrative project management support; work with CTEP and contracting project management staff to ensure the operational needs of the project are being met; collaborate with CTEP IDB, CDP and RAB staff to ensure associated correlative work is identified. - Ad-Hoc
• Work products and documents related to developing a new tracking and reporting system for the Biomarkers and Medical tests funding sources; monitor LOIs and protocols to make an early determination of associated correlative work funding mechanism (CRADA, MoCha, NCLN, grants, etc.) - Ad-Hoc
• Work products and documents related to providing support for the drafting and negotiation of Cooperative Research and Developments Agreements for NCI scientists and their industrial/academic research partners; ensure that agreements in the MATCH program are consistent with existing agreement and NCI/NIH policy. - Ad-Hoc
• Work products and documents related to creating data/ monitoring plans and providing regular written reports detailing progress against tasks and milestones; maintain the “Active Agreements” list on the CTEP Website of current CTEP Agents available for request; maintain the ACG SharePoint Page as requested. - Ad-Hoc

Statement of Work Details

• Provide scientific and administrative project management support. - 1
• Develop a new tracking and reporting system for the Biomarkers and Medical tests funding sources. - 2
• Generate appropriate SOPs and workflows for the new processes. - 3
• Monitor LOIs and protocols to make an early determination of associated correlative work funding mechanism (CRADA, MoCha, NCLN, grants, etc.). - 4
• Collaborate with internal and external stakeholders for intellectual property requirements, CRADAs, MTAs, etc. - 5
• Reviews, assesses and evaluates clinical trial design and feasibility.
• Reviews, evaluates and analyzes clinical trial data and study information.
• Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation.
• Assesses and supports meetings, clinical trial assessments and site visits.
• Formulates guiding principles and Standard Operating Procedures (SOPs) and prepares staff for clinical research.

Disclaimer

The above description is meant to illustrate the general nature of work and level of effort being performed by individuals 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.

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 on 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: [e-mail]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

Salary Range: $100,000 — $110,000 USD