The position requires 3 years of experience in the following: Applying ICH E6 (R2) Good Clinical Practice (GCP) and related ICH guidelines in the management of global clinical trials; Interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution; Managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements; Developing and monitoring Country Operational Plans (COPs), study timelines, milestone tracking, and enrollment forecasting; Managing and oversee external vendors, including Clinical Research Organizations (CROs), central laboratories, imaging vendors, and IRT providers; Utilizing Electronic Data Capture (EDC) systems including Medidata Rave for clinical data oversight and monitoring; Utilizing Electronic Trial Master File (eTMF) systems including Veeva Vault TMF to ensure documentation completeness and inspection readiness; Utilizing Clinical Trial Management Systems (CTMS) to track study progress, budgets, and performance metrics; Overseeing Interactive Response Technology (IRT/IWRS/IVRS) systems for enrollment tracking and investigational product management; Monitoring and analyzing time, cost, and quality performance metrics, including Key Performance Indicators (KPIs); Identifying, assessing, and mitigating regulatory and operational risks using risk-based quality management (RBQM) principles; Supporting and coordinating regulatory submissions, including ethics committee, IRB applications, health authority communications, and Supporting clinical-to-commercial transition activities to facilitate product commercialization and regulatory compliance; Leading or supporting regulatory inspections, internal audits, and CAPA development and implementation; Applying data integrity principles including ALCOA+ in oversight of clinical trial documentation and records; and. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, and flexible spending accounts.