Senior Clinical Trial Manager

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Senior Clinical Trial Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will lead, manage and co-ordinate the operational strategy, risk management, and overall execution 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 execution of clinical trial deliverables
• Support continuous improvement initiatives in Global Clinical Program Management (GCPM) and Global Development Operations (GDO)

Role Purpose:

• Maintain the quality and scientific integrity of clinical trials
• Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
• Support continuous improvement initiatives in Global Clinical Program Management (GCPM) and Global Development Operations (GDO)

Role description:

• Reports (at a minimum) to Global Clinical Program Management Senior Manager (CPM-SM)
• US and UK role based at Amgen offices and remotely

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 execution of clinical trials on time and within budget
• Management of vendors to the required standards
• Core member of Global Clinical Study Team (GCST)
• Maintaining global business relationships cross-functionally and communicating global status of clinical trial to senior management as needed
• Representing GCPM on process improvement initiatives
• 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
• Masters degree & 5 years of directly related experience or equivalent or
• Bachelors degree & 7 years of directly related experience or equivalent or
• Associates degree & 10 years of directly related experience or equivalent or
• High school diploma / GED & 12 years of directly related experience or equivalent

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

Knowledge

• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• 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

Key competencies

• Matrix team leadership
• Project Management
• Critical thinking and horizon scanning
• Problem solving
• Decision making
• Delegation skills
• Relationship Management and influencing skills
• Oral and written communication
• Time management
• Business English
• Organizational and planning skills
• Ability to work effectively in a team/matrix environment on multiple projects

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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#GDO2021

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.

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.