Sr. Manager - Clinical Trial Management
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.
Sr. Manager Clinical Trial ManagementLive
What you will do
Lets do this. Lets change the world. In this vital role you will support the Global Clinical Program Management Director (Clinical Trials) in the planning and execution of all studies for the program (accountable for all studies in the program if no director level present).
- Operational strategy and planning, program/study risk assessment and mitigation, and overall execution of clinical trials on time and within budget
- Provide clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan providing input into product global and regional evidence generation plans (product level)
- Maintain global business relationships cross-functionally and communicating program strategy and results of clinical trial programs to senior management and key partners
- Functional oversight of Global and Regional Clinical Trial Managers and collaboration with People and Resources Manager on performance management
- Initiate and support conduct of Country Operational Landscape Assessments and Targeted Local Feasibility in partnership with cross functional roles
- Development and oversight of clinical program budgets including change control in collaboration with Therapeutic Area and Finance
- Provide operational expertise throughout protocol design sessions coordinating cross functional input on a continuous basis
- Support / accountable for study global enrollment and accurate global recruitment forecasting, and implement and measure the success of subject recruitment and retention strategies
- Identify outsourcing requirements at a study / program level and supervise the identification, set-up, and management of CROs and vendors; may represent GCPM at Vendor Operational Management Teams; contribute to capability assessments for new vendors and participate in vendor qualification assessments
- Support and lead all aspects of internal audit, inspection activities, contribute to CAPAs globally and lead planning for regulatory agency inspection readiness activities (e.g. TMF review)
- Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and delivery; Contribute to development and maintenance of policies, SOPs and associated documents
- Facilitate sharing of standard methodologies and product knowledge within the function
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 proven leader with these qualifications.Basic Qualifications:
- Doctorate Degree OR
- Master's Degree and 2 years of Clinical experience OR
- Bachelor's Degree and 4 years of Clinical experience OR
- Bachelors of Nursing or Registered Nurse
- Masters degree in Life Science, Nursing or related field
- 7+ years work experience in Global Clinical Trials Management obtained working on clinical trials at a biotech, pharmaceutical or CRO company
- 3+ years project management and planning experience
- Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)
- Experience across phases I IV preferred
- Previous management experience of direct reports
- Experience in Oncology is preferred but not essential
- Experience in innovative trial design, adaptive trial design is preferred but not essential
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
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.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
Join UsIf 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.