Global Trial Manager

Career CategoryClinical DevelopmentJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Trial Manager Duties: Monitor work productivity or quality to ensure compliance with standard operating procedures; Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation; Oversee resolution of audit findings to ensure accuracy, completeness, or proper usage of clinical systems and data; Oversee the quality and scientific integrity of clinical operations for studies at a global level; Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables; Lead the Clinical Study Team to drive effective decision making; Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables; Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines; and Management of study budget and timelines; Management of vendors to the required standards. May Telecommute. Supervises Direct Reports. Requirements: Master’s degree (or foreign equivalent) in Biotechnology, Biology, Project Management or a related field & 3 years of experience in the job offered or in a Trial Study related occupation. Exhibit project management skills including leading study level planning of the overall clinical operation and maintaining study timelines; Experience with operational conduct of a study in startup, conduct, and close out phases, including but not limited to site identification, evaluation, selection, activation, and closeout; Development and review of clinical study-related documents; Vendor Management to ensure on time startup and delivery of services needed to conduct the clinical trial; Operations of clinical trials including: Study Planning & Trial Start-Up, Site Management & Oversight, Patient Recruitment & Retention, Trial Conduct & Data Quality, and Trial Budget & Financial Management; Resolving issues or risk mitigation for clinical trials including: slower projected enrollment, high rate of protocol deviations, safety concerns involving the investigational product, data quality problems, and site operational or quality concerns, budget or timeline variances; and Implement and conduct clinical trials in accordance with sponsor procedures and ICH-GCP guidelines. Contact: Interested candidates please apply via and search for job # R-248055 Job type: Full-Time position. The annual salary for this position in the U.S. is $185,806.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit  What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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 A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .SummaryLocation: US - California - Thousand OaksType: Full time