Clinical Studies Specialist

Position Title: Clinical Studies Specialist

Work Location: North Chicago, IL 60064

Assignment Duration: 12 Months

Work Arrangement: Onsite

Position Summary: This position is within clinical packaging operations under clinical drug supply management.

Background & Context: This person works directly with clinical supply project managers and drug supply managers.

Serves as the key interface between project management groups and liaison with packaging operations and QA teams. From a day-to-day perspective, a project manager or drug supply manager puts in a request for a packaging operation type job.

This person owns the support and readiness activities to ensure documentation, materials, and system setup activities are complete.

This person takes that job request and interprets it in the systems so it gets passed on to packaging operations as a useful sheet of information to execute the packaging operation. Ensures packaging activities are set up correctly and efficiently for processes, following GMP practices. Serves as the communication point for tracking task completion, dates, activities, logistics, and milestones and communicates that back to project management and drug supply managers. The group has six people.

verybody sits together in the same building and works closely together. From a task-based perspective, the work is quite independent. Looking for someone who can be independent, self-motivated, and drive tasks to completion without a high level of supervision. Team culture is very good and collaborative, and people step in and help each other. Individual tasks are assigned to each person, and they are responsible for completing them. There can be urgent requests such as manufacturing stoppages where people need to support each other and pivot.

This is not a role for someone who waits to be told what to do. The role is as much or as little as you make of it. There are lots of different task-based activities and lots of systems that someone can become like an expert in. The more someone learns and promotes themselves, the better chance they may have for a full-time opportunity. Less successful cases are people who sit back and wait to be told what to do, do not take initiative, do not take on additional work when work is less, and require more micromanagement. The team uses many systems, which are homegrown systems specific to our organization clinical work.

They are not standard systems like SAP and are not directly comparable to external systems. Someone with system experience such as SAP or similar is acceptable as they understand concepts and can adapt. Looking for someone who can learn systems quickly and adapt to the environment. Looking for someone with at least around three years of relevant experience. Preferably in a clinical trial environment, but pharmaceutical or GMP experience is also acceptable.

Key Responsibilities:

* This person works directly with clinical supply project managers and drug supply managers.

* Serves as the key interface between project management groups and liaison with packaging operations and QA teams.

* From a day-to-day perspective, a project manager or drug supply manager puts in a request for a packaging operation type job.

* This person owns the support and readiness activities to ensure documentation, materials, and system setup activities are complete.

* This person takes that job request and interprets it in the systems so it gets passed on to packaging operations as a useful sheet of information to execute the packaging operation.

* Ensures packaging activities are set up correctly and efficiently for processes, following GMP practices.

* Serves as the communication point for tracking task completion, dates, activities, logistics, and milestones and communicates that back to project management and drug supply managers.

Qualification & Experience:

* Bachelor's or Master's degree with a scientific focus.

* Around three years of experience with a Bachelor's degree or around two years with a Master's degree, with relevant experience.

* Experience in a clinical trial environment is preferred. * Pharmaceutical or GMP experience is acceptable.

* Experience working in a GMP-type environment where they are used to looking up documentation, understanding requirements, and forecasting issues.

* Some level of project management experience. * Ability to work independently and drive tasks to completion without a high level of supervision.

* Ability to learn systems and adapt to internal, homegrown systems.