Applying ICH E6 (R2) Good Clinical Practice (GCP) and related ICH guidelines in the management of global clinical trials; 2. Interpreting and implementing FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312) and other applicable regulatory requirements in clinical trial execution; 3. Managing clinical trial activities from study start-up through close-out in accordance with regulatory and protocol requirements; 4. Developing and monitoring Country Operational Plans (COPs), study timelines, milestone tracking, and enrollment forecasting; 5. 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.