Global Clinical Trial Manager - Early Development (US-Remote)

Career CategoryClinicalJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Global Early Clinical Development Manager (GECDM)LiveWhat you will doLet's do this. Let's change the world. In this vital role you will be a part of our Global Development Operations and be accountable for the implementation, management and reporting of early development clinical trials (phase 0 - 1b). You will also be a member of one or more cross-functional clinical study teams and a core member of the evidence generating team. These programs focus on the rapid development of emerging New Molecular Entities (NMEs) and require implementation of novel and highly flexible global operational strategies.Global Early Clinical Development Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.Responsibilities:Leads study level planning of the overall clinical operation resultsDevelops early phase clinical operation strategy and contributes to strategic scenario planning in clinical development planDevelops and maintains study timeline and development of clinical protocol and informed consentContributes to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.Leads clinical study team to identify, evaluate and select clinical sitesHandles the day-to-day operations of clinical trial at a global level and resolves issues called out by the local study teamMaintains close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the studyTrains study team members and/or sites to conduct the studyLeads and coordinates Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomesManages vendors and functional service providers (FSP)WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is a study manger with these qualifications.Basic Qualifications:Master's degree and 3 years of clinical experience ORBachelor's degree and 5 years of clinical experiencePreferred Qualifications:Bachelor's Degree or equivalent required (scientific or healthcare field preferred).4years of experience of clinical research and study managementExperience in clinical program managementSubstantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.The annual salary range for this opportunity in the U.S. is $117,785- $136,224.In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including: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.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.PDN-962cc6b2-9eeb-4b01-a4d8-d8fd2122a045