Clinical Vendor Qualification Associate - INFOTREE GLOBAL SOLUTIONS : Job Details

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:

Preferred Skills: