Clinical Vendor Associate

Key Responsibilities:Lead and support cross-functional efforts in vendor qualification, capability assessments, sourcing, and inspection readiness.Ensure compliance with Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and ICH E6 R2.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 (BSBA) is required.Experience: 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry, with strong knowledge of quality and compliance standards.Project Management: Experience in managing projects in the pharmaceutical or healthcare industry. PMP certification or equivalent is preferred.R&D Clinical Procurement: Hands-on experience in clinical procurement is essential.Skills: Excellent communication, critical thinking, and project management skills with the 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, RWDRWE, biostatistics, medical writing, central lab services, and more.

Created: 2025-02-23