To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

• Clinical Studies Specialist position within the Clinical Supply Chain Organization based in the packaging and operations group
• System and data setup role in packaging operations and organization
• Acts as a conduit between project management and operations team
• Translate information for project manager planning for clinical supplies and translating this information for packaging team to execute
• Relevant experience includes
• Clinical Trial, CRA, Supply Chain Management, Operational/Manufacturing, QA with device/pharma/operations

Education Requirement:

• Bachelor’s Degree required preferably in physical science, math, engineering, and pharmacy or data science.
• Experience – 2-4 years total experience in the cIndustry.

 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).