When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is hiring multiple Clinical Supply Support Specialist Services .The position will be office based in Warren, New Jersey.
Clinical Supply & Inventory Planning & Execution
Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)
Pull relevant data for metrics reporting & maintain metrics
Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies
Track and manage comparator documentation updates
Clinical Supply Shipments
Initiate non-system generated shipments
Monitor and track comparator drug delivery schedules
Coordinate Depot transfers & site return shipments
Temperature excursion management and resolution
Clinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
Expected Document List (EDL) creation
Update comparator IMN (Item Master Number)
Update and maintain eTMF Document Management per regulatory requirements Request QA/QP Releases
Pack-and-label kit and sequence reconciliation
Inspection Readiness activities
IRT management activities, including IRT Alert management and UAT activities
IP / Ancillary Supplies Compatibility Review
Receive and triage request, forward to FDG for review
Perform internet searches and contact manufacturers for information
Data entry of information into database (ASIST or spreadsheet) and Teams
Clinical Supply Systems
Manage CSS Email Inbox
Manage IRT system access for users for all studies
Complete EDL, IRR and StiL reviews every 3 months for all studies
Manage all TMF documentation uploads into VEEVA
Assist in UAT testing
Minimum education requirements:
Bachelor's degree in a related field with an internship or prior industry work experience.
Preferred 2+ years of experience in the following fields:
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The expertise and passion for excellence shared by our people around the world unites us in our mission and drives our success. As a premier service provider to the global biopharmaceutical industry, we give you the opportunity to work with industry-leading clients in an exciting, collaborative environment where career choices and development paths are abundant, and projects are challenging. In fact, PAREXEL works with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. With over 30 years of experience, we have supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market.
We offer our employees the ability to make a difference globally, while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.
Discover a career at PAREXEL, where exciting challenges and opportunities await you.