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Vendor/ Clinical Supplies Manager

HK Recruiting

Vendor/ Clinical Supplies Manager

National
Full Time
Paid
  • Responsibilities

    Our client is a global, clinical stage biopharmaceutical company focused on the development of an innovative pipeline of new chemical entities with known mechanisms of action targeting underserved patient populations in organ protection and infectious diseases. Our client utilizes an integrated discovery and development platform that enables the company to efficiently bring new therapies from bench to patients around the world.


    PRIMARY DUTIES:
    • Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines;
    • Management of vendor oversight requirements and documentation.
    • Providing guidance and support activities to study team members for all vendor oversight.
    • Standardization of vendor oversight requirements and reporting.· Process Improvement to existing methods / Establishing best practices for current SOPs.
    • Support Vendor audit/inspection Corrective and Preventative Action (CAPA) response & management.
    • Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan;
    • Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends by performing routine forecasting / demand planning.
    • Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals;
    • Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated
     
    EDUCATION AND EXPERIENCE:
    • Bachelor's degree required with an advanced degree preferred;· At least 5 years of relevant industry experience,
    • First-hand experience of working directly with Contract Service Providers (CSPs), investigators, customers, and clinical development teams;
    • Experience in process improvement for vendors in clinical trial setting;
    • Experience developing trial drug supply plans;
    • Investigational Product forecasting skills;
    • Working knowledge of the clinical drug development process and clinical trial methodology;
    • Knowledge of ICH/GCP and regulatory guidelines/directives