Mgr Supplier Management
Full-timeMIDNeurology
Description
<h2><b>Career Category</b></h2>Project Management<h2></h2><h2><b>Job Description</b></h2><p><b>Leadership</b></p><ul><li>Provide oversight, management, and mentorship to Associate roles</li><li>Engage and delegate appropriately</li><li>Ensure transparency through excellent communication</li><li>Generate and maintain process playbooks</li><li>Facilitate training of new staff</li><li>Ensure timely completion of all assigned training</li></ul><p><b>Program & Study Planning</b></p><ul><li>Host and manage meetings both internally and with external suppliers to minimize risk and optimize delivery of results.</li><li>Plan and forecast study budgets; own early planning in Planisware.</li><li>Obtain Life of Study budget approvals through study leads.</li><li>Proactively manage budgets, purchase orders, and change orders.</li><li>Liaise with study team members and other relevant cross‑functional stakeholders to ensure adherence to quality and timeline deliverables.</li><li>Review draft protocols for accuracy and update budget requirements and study timelines as needed</li></ul><p><b>CRO & Vendor Management</b></p><ul><li>Serve as point of contact between external suppliers and internal stakeholders</li><li>Assist in supplier evaluation, onboarding, and monitoring</li><li>Assign staff and studies to activities and ensure awareness of all stages of method transfer, study support, and reporting</li><li>Execute CRO study contracts using specifications provided or reviewed by study team members.</li><li>Ensure timely completion of training assigned to CROs/External Workers</li><li>Manage analytical method support documentation including dosing documents, reagent qualifications, reagent expiry extensions, and reports</li><li>Manage CRO deliverables, timelines, invoices, and contract budgets.</li><li>Coordinate transfer of documents, data, and materials to/from CROs.</li><li>Ensure documents are stored in compliant locations (eg rIM, TMF)</li><li>Collaborate with CROs to generate analytical plans.</li><li>Ensure CRO flags reagent expiration risks and maintain accurate reagent tracking.</li><li>Monitor reagent inventory, expiration dates, and ensure timely replenishment.</li></ul><p><b>Material & Sample Management</b></p><ul><li>Oversee material procurement, shipping, and logistics coordination.</li><li>Coordinate transfers of critical reagents, including to secondary CROs when needed.</li><li>Request BA Lab Ops support for vial labeling as needed.</li><li>Communicate shipment details to CROs.</li><li>Execute sample disposition strategy.</li></ul><p><b>Cross‑Functional Communication & Alignment</b></p><ul><li>Manage and lead recurring cross-functional meetings</li><li>Provide critical updates to stakeholders and ensure alignment on major discussions.</li><li>Inform BA of upcoming requirements (new indications, BE studies, geographies, co‑med considerations).</li><li>Update CST on timeline changes and bring in BAPS/SMPA when needed.</li><li>Notify BAPS and SMPA of significant report issues and escalate delays or quality concerns.</li><li>Contribute to study plan development and maintenance of external collaboration sites.</li></ul><p><b>Protocol, Timeline & Issue Management</b></p><ul><li>Review study protocols and amendments for collection timepoints and testing strategy.</li><li>Populate study timeline trackers and maintain issue trackers.</li><li>Coordinate with Associates for RIM requests and facilitate document review cycles.</li><li>Request reviews from stakeholders and coordinate scientific reviews as needed.</li><li>Archive final study documents and provide study index and correspondence in RIM.</li></ul><p><b>Reporting & Documentation</b></p><ul><li>Provide final reports to medical writers, RS, CI‑PTR, and CPMS.</li><li>Communicate any supplier issues and support remediation efforts.</li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.
Amgen
BIOTECHNOLOGY
Small Molecules, Biologics
LocationTHOUSAND OAKS, CA
Employees27,000
Open Jobs1215
OncologyCardiovascularBone HealthImmunologyNeuroscience
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