Position Title: Clinical Studies Specialist II
Location: Lake County, IL
Length of Contract: 12 Months (possible extension)
Job Description:
• Major Responsibilities:
o 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.
o Translates stability and packaging requests into an executed packaging design.
o 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
o Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with the clinical supply project manager.
o Responsible to complete tasks identified for the team.
o Responsible for inventory management system set up activities (i.e. Material masters, manufacturing requests, etc) to support clinical packaging operations
• Critical Success Factors
o A basic understanding of clinical development and global supply chain requirements.
o Competent in the application of standard business requirements (for example SOPs, Global Regulations).
o Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
o Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
o Ability to work effectively and professionally with those in the dept as well as QA, Analytical and any area interface.
o Ability to manage and prioritize multiple tasks.
o Basic Project Management skills.
o Good communication skills (both written and oral).
What are the top 3-5 skills, experience or education required for this position:
1. Bachelors or Master’s 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
Qualification:
• 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.
EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
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