Clinical Studies Specialist II

job summary:
Step into a pivotal role where your expertise in clinical supply chain logistics directly impacts the delivery of life-changing medicines to global clinical sites. You will serve as a key driver in the planning and execution of investigational drug supplies, transforming complex stability and packaging requirements into tangible results. This is a high-impact opportunity to sharpen your project management skills within a fast-paced, regulated environment that rewards independent thinkers and proactive problem-solvers.

Located in a premier, state-of-the-art facility in North Chicago, the campus offers a dynamic, collaborative environment equipped with modern amenities designed to foster innovation and cross-functional teamwork. As a Clinical Studies Specialist II, you will balance the best of both worlds with a hybrid schedule, utilizing onsite resources to interface with Quality Assurance and Analytical teams while maintaining the flexibility of remote work days.

location: North Chicago, Illinois
job type: Contract
salary: $28.00 - 32.98 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Coordinate and execute the timely availability of investigational drug supplies and services to clinical sites and depots worldwide.
• Translate stability data and packaging requests into actionable, executed packaging designs for clinical trials.
• Identify, communicate, and track critical task completion dates and logistics milestones to support the Clinical Supply Project Manager.
• Create protocol-specific manufacturing and packaging work orders in alignment with project timelines.
• Manage inventory system setups, including the creation of Material Masters and manufacturing requests, to support seamless packaging operations.
• Maintain strict adherence to SOPs and global regulations to ensure compliance in a highly regulated pharmaceutical environment.
• Collaborate cross-functionally with QA and Analytical departments to ensure all clinical supplies meet stringent quality standards.

qualifications:
Required Skills

• Education: Bachelor's degree in Physical Science, Math, Engineering, Pharmacy, or Data Science.
• Industry Experience: 3-5 years of professional experience within the Pharmaceutical Industry.
• Clinical Environment: Proven experience working within a clinical trial environment.
• Regulatory Knowledge: Basic understanding of clinical development, global supply chain requirements, and SOP compliance.
• Soft Skills: Ability to work independently, manage multiple priorities, and possess strong written and oral communication skills.

Preferred Skills

• Advanced Education: Master's degree with a scientific focus.
• Systems Expertise: Direct experience with Materials Management Systems (SAP, Oracle, etc.) within a pharmaceutical context.
• Project Management: Demonstrated basic project management skills and the ability to drive tasks to completion with minimal supervision.

#LI-ST1

skills: Clinical Trial Management Systems (CTMS), Clinical Packaging Operations


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.