Scientific Program Manager

3 weeks ago

Rockville, United States Axle Full time
Job DescriptionJob Description

(ID: 2024-5210)

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).

Benefits:

  • 100% Medical, Dental & Vision Coverage for Employees
  • Paid Time Off (Including Holidays)
  • Employee Referral Bonus
  • 401K Match
  • Tuition reimbursement and professional development opportunities
  • Flexible Spending Accounts:
    • Healthcare (FSA)
    • Parking Reimbursement Account (PRK)
    • Dependent Care Assistant Program (DCAP)
    • Transportation Reimbursement Account (TRN)
Overview:
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Allergy, Immunology, and Transplantation (DAIT).

Technical Requirements:
  • Audit operations and systems to assess client satisfaction, conformance with SOP's and regulatory compliance.
  • Audit clinical study files held by the CRO.
  • Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations. • Identify Gap analysis of existing SOPs.
  • Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.
  • Audit operations and systems to assess client satisfaction, conformance with SOPs and regulatory compliance.
  • Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations.
  • Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.

Specific Qualifications:
  • Bachelor's degree in a related field.
  • Minimum of seven (7) years experience as an Auditor Lead conducting reviews and audits of regulatory and clinical trial documents (trial master file documents) as related to ICH E6 guidelines, GxP, and applicable FDA regulation.
  • Knowledge of GxP
  • Proficient in electronic systems used in clinical trials (such as Veeva, SharePoint, Electronic Data Capture, etc. and other quality management systems)

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.

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