Demo

Clinical Vendor Qualification Associate

Infotree Global Solutions
San Mateo, CA Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/11/2025

Key Responsibilities :

  • Lead and support cross-functional efforts in vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness.
  • Understand clinical trial processes, including clinical monitoring, data management, Real World Data / Evidence (RWD / RWE), biostatistics, medical writing, and key services such as central and biomarker labs, eCOA, safety, and telemedicine.
  • Conduct RFIs, IT security assessments, anti-bribery and corruption due diligence, subcontractor management, financial health assessments, and inspection readiness.
  • Provide data-driven insights through analyses and benchmarking for strategy and continuous improvement initiatives.
  • Prepare and deliver presentations and training to internal teams and external vendors.
  • Collaborate with internal departments such as R&D Quality & Compliance, clinical operations, finance, legal, and vendor relationship management.
  • Manage competing priorities with minimal supervision.

Qualifications :

  • BS or BA is required (no exceptions).
  • 5 years of experience in the pharmaceutical or biopharmaceutical industry.
  • Strong project management skills, ideally with experience in pharmaceutical or healthcare industries.
  • PMP certification or equivalent preferred.
  • In-depth knowledge of GCP, GVP, GLP, GDP, and ICH E6 R2 compliance.
  • Required Skills :

  • R&D Clinical Procurement experience.
  • Project management expertise (current or former project managers).
  • Strong knowledge of quality and compliance within the pharmaceutical or healthcare sectors.
  • Preferred Skills :

  • Experience in Vendor Qualification.
  • Vendor Outsourcing knowledge.
  • Vendor Contracting experience.
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