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Clinical Vendor Associate

5+ years
Not Disclosed
10 March 4, 2025
Job Description
Job Type: Full Time Education: BS/BA Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Clinical Vendor Associate

Location: Foster City, CA
Employment Type: Hybrid, Contract
Salary: $40/hr - $45/hr
Posted: 1 week ago

Key Responsibilities:

  • Lead and support cross-functional efforts in vendor qualification, capability assessments, sourcing, and inspection readiness.
  • Ensure compliance with GCP, GVP, GLP, GDP, and ICH E6 R2 regulations.
  • Conduct Request for Information (RFI), Data Privacy and Security IT Assessments, Anti-Bribery and Anti-Corruption Due Diligence, and Vendor Subcontractor Process Management.
  • Perform financial health assessments and contribute to inspection readiness preparation activities.
  • Analyze data and provide insights to drive continuous improvement initiatives.
  • Create presentations and deliver training to internal teams and external stakeholders.
  • Collaborate with R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and external vendors.
  • Manage tasks and projects independently, prioritizing competing demands.

Key Qualifications:

  • Education: Bachelor’s degree (BS/BA) required.
  • Experience: 5+ years in the pharmaceutical or biopharmaceutical industry with strong knowledge of quality and compliance standards.
  • Project Management: Experience managing projects in the pharmaceutical or healthcare industry; PMP certification preferred.
  • Clinical Procurement: Hands-on experience in clinical procurement is essential.
  • Skills: Excellent communication, critical thinking, and project management skills; ability to interact effectively with internal and external stakeholders.

Preferred Skills:

  • Experience in vendor qualification, outsourcing, and contracting.
  • Familiarity with clinical trial activities such as clinical monitoring, data management, RWD/RWE, biostatistics, medical writing, central lab services, and more.