Clinical Contract Manager

We are seeking a Clinical Contract Manager to lead the end-to-end clinical site contracting process in support of our growing clinical portfolio.

Requirements

• 5+ years of trial management experience with 3+ years in site management
• Bachelor’s degree in Life Sciences, Pharmacy or related field
• Experience working in global clinical development organization
• Experience in Oncology development (preferred)
• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)
• Experience in outsourcing and oversight
• Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs
• Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act)
• Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines