Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)

Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)

13 Oct 2024
District of Columbia, Washington 00000 Washington USA

Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)

Join Amgen’s Mission of Serving PatientsAt 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.Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)What you will doLet’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.Sr Global Trial Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.

Leads study level planning of the overall clinical operation results

Develops late phase clinical operation strategy and contributes to strategic scenario planning in clinical development plan

Develops and maintains study timeline and development of clinical protocols and informed consents

Contributes 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 sites

Handles the day-to-day operations of clinical trial at a global level and resolves issues called out by the local study team

Maintains close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study

Trains study team members and/or sites to conduct the study

Leads and coordinates Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes

Manages vendors and functional service providers (FSP)

Line Management of Global Trial Managers (GTMs) and Local Trial Managers (LTMs)(study dependent).

What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Sr. Manager with these qualifications.Basic Qualifications:

Doctorate degree and 2 years of clinical research experience or

Master’s degree and 6 years of clinical research experience or

Bachelor’s degree and 8 years of clinical research experience or

Associate’s degree and 10 years of clinical research experience or

High school diploma / GED and 12 years of clinical research experience

Preferred Qualifications:

Bachelor’s Degree or equivalent required (scientific or healthcare discipline preferred).

7+years of experience of clinical research and study management

Experience in clinical program management

Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs

Offered Salary Range: $147,676 - $173,028What you can expect of usAs 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn 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.Application deadlineAmgen 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.

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