IMP

Term from Clinical Trials industry explained for recruiters

IMP (Investigational Medicinal Product) refers to medicines or placebos being tested in clinical trials. It includes new drugs under development, existing medications being studied for new uses, or comparison products used in research. When you see this term in resumes or job descriptions, it relates to the handling, management, or documentation of these test medicines during clinical studies. This is a key term in clinical research, especially in roles involving drug trials or pharmaceutical research.

Examples in Resumes

Managed distribution and tracking of IMP supplies across 12 international clinical trial sites

Developed standard procedures for IMP and Investigational Medicinal Product handling and storage

Coordinated with sponsors on IMP accountability and reconciliation for Phase III trials

Typical job title: "Clinical Trial Supply Managers"

Also try searching for:

Clinical Supply Manager IMP Manager Clinical Trial Supply Coordinator Clinical Research Associate Drug Supply Coordinator Clinical Supply Chain Manager Clinical Trial Material Manager

Example Interview Questions

Senior Level Questions

Q: How would you handle a temperature excursion for temperature-sensitive IMPs at multiple trial sites?

Expected Answer: A senior manager should explain the process of immediate notification, documentation, assessment of impact, communication with sponsors and sites, and implementing corrective actions. They should also mention experience with creating preventive measures for the future.

Q: How do you ensure compliance with different countries' regulations for IMP handling?

Expected Answer: Should discuss experience with various regulatory requirements (like EU, FDA guidelines), maintaining documentation, training site staff, and coordinating with local regulatory experts to ensure compliance in different regions.

Mid Level Questions

Q: What systems do you use for IMP tracking and inventory management?

Expected Answer: Should be able to describe experience with clinical trial management systems, inventory tracking tools, and processes for maintaining accurate records of drug receipt, storage, and dispensing.

Q: Explain your process for IMP reconciliation at the end of a trial.

Expected Answer: Should describe the steps for accounting for all used and unused medication, documentation requirements, working with sites for returns, and proper disposal procedures.

Junior Level Questions

Q: What are the basic storage requirements for IMPs?

Expected Answer: Should know about temperature monitoring, secure storage areas, access control, and basic documentation requirements for storing investigational products.

Q: What documentation is required when receiving IMP shipments?

Expected Answer: Should be able to explain basic receiving procedures, checking temperature monitors, verifying quantities, completing receipt forms, and proper filing of documentation.

Experience Level Indicators

Junior (0-2 years)

  • Basic IMP documentation
  • Temperature monitoring
  • Storage procedures
  • Simple inventory tracking

Mid (2-5 years)

  • IMP shipment management
  • Site supply coordination
  • Inventory forecasting
  • Temperature excursion handling

Senior (5+ years)

  • Global supply chain management
  • Regulatory compliance oversight
  • Strategic planning
  • Vendor management

Red Flags to Watch For

  • No knowledge of Good Clinical Practice (GCP) guidelines
  • Lack of experience with temperature monitoring and cold chain management
  • Poor understanding of documentation requirements
  • No experience with clinical trial management systems

Related Terms