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| Company Name: |
Ultimate Staffing Services |
| Location: |
King Of Prussia, PA United States |
| Position Type: |
Full Time |
| Post Date: |
03/26/2023 |
| Expire Date: |
06/16/2023 |
| Job Categories: |
Accounting/Auditing, Manufacturing and Production, Executive Management, Quality Control, Research & Development |
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Clinical Trial Supply (CTS) Study Manager (JO-2303-197500)
We are seeking a Clinical Trial Supply Manager to work on a team in the King of Prussia, PA area. One day per week is required to be onsite.
Job Description:
The Clinical Trial Supply (CTS) Study Manager is responsible for managing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Study Manager independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients. The role includes determining kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. The CTS Study Manager also leads process improvement projects for the clinical supply chain.- Gives input to and oversees the implementation and execution of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.
- Gathers and documents requirements for clinical supplies based on protocol attributes and clinical assumptions.
- Leads demand forecasting for study(ies); leverages simulation and optimization tools capabilities to optimize clinical supply plans and minimize the effect of inherent uncertainties; adjusts plans monthly based on actual consumption and changes to clinical and/or supply assumptions; confirms supply plans.
- Specifies ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.
- Presents IMP related CTS topics in Study Execution Teams.
- Determines labelling and clinical kit design based on protocol and countries' needs; implements pooling concepts in the study.
- Establishes and monitors global network of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.
- Coordinates timely and compliant importation and resupply of drug supplies and ancillary supplies into regional and global depots. Manages the inventory levels and product expiry.
- Ensures on time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients.
- Develops clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration videos).
- Trains external stakeholders (i.e,. clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.
- Files proper documentation throughout the study and after study closure.
- Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites.
- Co-develops IRT specifications for drug supply management, participates in user acceptance testing and establishes and monitors inventory levels and IRT resupply settings. Adjusts system settings based on study progress and changes to clinical and/or supply assumptions.
- Generates study specific Request for Proposals based on study assumptions, creates Purchase Orders, reviews and approves invoices.
- Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participates in GxP audits and regulatory inspections as needed.
- Investigates deviations, product technical complaints and temperature excursions (site and transport) in collaboration with CSQ.
- Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities.
- Ensures Plateau SOP training is complete in time.
- Creates and updates budgets for complex studies including product and packaging and labeling costs, storage and distribution costs, and comparator a
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| Company Name: |
Ultimate Staffing Services |
| Website: | https://careers.ultimatestaffing.com/job/234601/Clinical-Trial-Supply-(CTS)-Study-Manager?ApplyNow=true&board=HBCU |
Company Description:
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