What are the responsibilities and job description for the Clinical Studies Specialist II position at US Tech Solutions?
Duration: 12 months (With Possibility of Extension)
Work schedule:
- Hybrid required (M/F Remote - T/W/TH Onsite).
- 1 year with possible extension - based on performance and business needs.
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/Preferences:
- 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.
- Communication skills.
- Also interested in expanding to candidates with materials management systems experience, ideally in pharma context.
Education and experience:
- Bachelor’s or Master’s degree with a Scientific focus or preferably in physical science, math, engineering, pharmacy or data science.
- 3-5 years of pharmaceutical experience, preferably in a clinical trial environment.
- Ability to work independently and drive tasks to completion without high level of supervision.
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.
Contact Details:
Name: Shivangi Shivpuri
Email: shivangi.s@ustechsolutionsinc.com
Internal Id: 26-08129
Salary : $29 - $31