What are the responsibilities and job description for the Clinical Studies Specialist II position at Planet Pharma?
Target PR Range: 20-30/hr
- Depending on experience
- 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).