Clinical Studies Specialist II

Clinical Studies Specialist II
Location: North Chicago, IL
Hybrid Required (M/F Remote - T/W/TH Onsite)
Contract: 1 year with possible extension - based on performance and business needs
Hourly Pay Rate: $28-31/hr (individual medical benefits available at a cost)

What are the top 3-5 skills, experience or education required for this position:
1. Bachelors or Masters degree with a Scientific focus
2. 3-5 years of pharmaceutical experience, preferably in a clinical trial environment
3. Ability to work independently and drive tasks to completion without high level of supervision

Education Requirement:

• Bachelor’s Degree required preferably in physical science, math, engineering, pharmacy or data science.
• Experience – 3-5 years total experience in the Pharmaceutical Industry.

Major Responsibilities:

• Planning, scheduling, coordination and execution, in support of clinical supply project manager to ensure the timely availability of investigational drug supplies and related services to clinical sites and depots.
• Translates stability and packaging requests into an executed packaging design.
• Identifies, develops, communicates and tracks task completion dates , activities, logistics, and milestones in support of clinical supply project manager to ensure the timely availability of investigational drug supplies
• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with the clinical supply project manager.
• Responsible to complete tasks identified for the team.
• Responsible for inventory management system set up activities (i.e. Material masters, manufacturing requests, etc) to support clinical packaging operations

 Critical Success Factors:

• A basic understanding of clinical development and global supply chain requirements.
• Competent in the application of standard business requirements (for example SOPs, Global Regulations).
• Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
• Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
• Ability to work effectively and professionally with those in the dept as well as QA, Analytical and any area interface.
• Ability to manage and prioritize multiple tasks.
• Basic Project Management skills.
• Good communication skills (both written and oral).

 Preferred Skill:

• The manager is also interested in candidates with materials management systems experience, ideally in pharma industry.

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