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Clinical Studies Specialist II
Job Description
Target PR Range: 20-30/hr
*Depending on experience
Major Responsibilities:
o 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.
o Translates stability and packaging requests into an executed packaging design.
o 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
o Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with the clinical supply project manager.
o Responsible to complete tasks identified for the team.
o Responsible for inventory management system set up activities (i.e. Material masters, manufacturing requests, etc) to support clinical packaging operations
• Critical Success Factors
o A basic understanding of clinical development and global supply chain requirements.
o Competent in the application of standard business requirements (for example SOPs, Global Regulations).
o Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
o Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
o Ability to work effectively and professionally with those in the dept as well as QA, Analytical and any area interface.
o Ability to manage and prioritize multiple tasks.
o Basic Project Management skills.
o Good communication skills (both written and oral).
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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