PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
This position is responsible for supporting CSO Project management by enabling the on-time delivery of clinical supplies projects across the Client portfolio. This role is primarily responsible for supporting CSO Project Manager’s by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1. Develops and updates Study Supply Plans in close communication with CSO project Managers.
2. Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
3. Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and other CSO personnel.
4. Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
5. Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study requirements. Reviews IRT specifications, participates in UAT as requested and maintains settings in IRT to align with supply plans.
6. Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
7. Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship
8. Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.
9. Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
10. Supports the CSO PM in executing additional operational and logistical duties as discussed and agreed to by management.
11. Acts as point of contact for operational clinical supply matters during the course of a clinical trial including facilitating the review of temperature excursions.
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