TMF - Clinical Advisor

4 weeks ago

Rockville, United States Axle Full time
Job DescriptionJob Description

(ID: 2024-5258)

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 TMF - Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO).

Technical Requirements:

  • Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files.
  • Serve as the primary reviewer of TMF deliverables including but not limited to standard TMF reports, TMF messages, and TMF documents in electronic systems.
  • Manage and design TMF related trainings for DAIDS and collaborators and present proposals/materials to the federal client for approval prior to implementation.
  • Coordinate and communicate to provide support and guidance to various functional areas supporting DAIDSTMFs.
  • Provide support of DAIDS TMF operations during TMF implementation, audits, and/or regulatory inspections.
  • Ensure TMF's are "inspection ready" at all times and TMF documents are filed contemporaneously.
  • Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation.
  • Represent DAIDS on working groups and committees to communicate information regarding TMF policies, procedures, and requirements.
  • Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and collaborators.
  • Establish quality assurance standards and metrics for TMF policies and procedures.
  • Ensure DAIDS compliance with all regulations, policies and procedures related TMFs.
  • Participate in working groups and team meetings, as required.
  • Develop SOPs as required to ensure oversight of the DAIDS TMF process.

Specific Qualifications:

  • BS degree is required, MS preferred.
  • Minimum of 3-5 years of TMF specific experience is required.

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.

#IND, #LI-NT1

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