Senior Clinical Trial Manager (US-Remote)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Senior Clinical Trial Manager (US-Remote)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead, manage and co-ordinate the operational strategy, risk management, and overall delivery of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations.
  • Maintain the quality and scientific integrity of clinical trials
  • Collaborate with cross functional stakeholders to ensure timely and on budget implementations of clinical trial deliverables
  • Support continuous improvement initiatives in Global Clinical Program Management (GCPM) and Global Development Operations (GDO)


Responsible for:

  • Line Management of Global Clinical Trial Managers (GCTMs)
  • Leading the Clinical Study Team to drive effective decision making
  • Managing study-level operational issues and study team issue escalation
  • Defining clinical trial strategic operational plan, and managing risk assessment and mitigation
  • Ensuring implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
  • High quality delivery of clinical trials on time and within budget
  • Management of vendors to the required standards
  • Maintaining global business relationships cross-functionally and communicating global status of clinical trial to senior management as needed
  • Support GCPM resource planning for assigned program(s) in collaboration with PRM Lead and CPM-SM


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is a driven leader with these qualifications.

Basic Qualifications

  • Doctorate degree or
  • Master's degree & 5 years of directly related experience or equivalent or
  • Bachelor's degree & 7 years of directly related experience or equivalent or


Preferred Qualifications

  • BA/BS/BSc
  • 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Minimum 5 years experience in leading global teams
  • Extensive knowledge of ICH/GCP regulations and guidelines
  • Project and Program management including oversight of study deliverable, budgets and timelines
  • Time, cost and quality metrics, Key performance indicators (KPIs)
  • Relevant therapeutic knowledge
  • Relationship Management and influencing skill
  • Ability to work effectively in a team/matrix environment on multiple projects


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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