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Title: Clinical Studies Specialist II
Location: Lake County - Onsite
Contract: 1 year
Education Requirement:
Bachelor’s Degree required preferably in physical science, math, engineering, pharmacy or data science.
Experience – 2-4 years total experience in the Pharmaceutical Industry.
Top 3-5 skills / experience
Cross functional, project management experience
Pharma clinical experience, ideally specifically as it relates to clinical supplies
Supply chain/master data experience
Working with a GMP environment, following SOPs, interfacing with Quality organizations
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).
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.