Clinical Studies Specialist II

Job DescriptionTarget PR Range: 19-29/hrDepending on experience 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 suppliesResponsible 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 FactorsA 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).Also interested in expanding to resumes with materials management systems experience, ideally in pharma context.The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.