Study Delivery Senior Manager – Study Delivery Lead
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Job Description
Leading end-to-end global clinical trial delivery for Amgen, a biotechnology company developing innovative medicines. Managing study teams, vendors, risks, timelines, budgets, and data quality.
Responsibilities:
- Own end-to-end delivery of assigned global clinical studies, with accountability for quality, timelines, budget, and operational performance
- Lead and align cross-functional study teams to deliver high-quality clinical data in line with the evidence generation strategy
- Define and implement study plans covering feasibility, site selection, site engagement, recruitment and retention, and vendor delivery
- Identify and manage study risks using quality-by-design and risk-based approaches to ensure participant safety and data integrity
- Oversee global study execution, including enrollment, data flow, monitoring, and corrective actions
- Provide leadership, direction, and escalation management to resolve complex study issues across geographies
- Build partnerships with internal stakeholders and external vendors to ensure effective collaboration and performance
- Champion continuous improvement, innovation, and regulatory compliance throughout clinical trial delivery
Requirements:
- Doctorate degree and 2 years of Clinical Execution experience, or Master’s degree and 4 years of Clinical Execution experience, or Bachelor’s degree and 6 years of Clinical Execution experience, or Associate’s degree and 10 years of Clinical Execution experience, or high school diploma/GED and 12 years of Clinical Execution experience
- 7 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained leading global clinical trials in a biotech, pharmaceutical or CRO company
- Experience managing direct reports across multiple geographies
- Experience representing a sponsor company in regulatory audit/inspections
- Experience at or oversight of outside clinical research vendors, including CROs, central labs, and imaging vendors
- Sponsorship for this role is not guaranteed
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance support
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