Clinical Study Planning Manager
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Clinical Study Planning Manager
What you will do
Lets do this. Lets change the world. In this vital role you will be a part of Global Development Operations (GDO). You will drive cross functional planning and effective execution of studies through the development of realistic study timelines and objective communication of project status to maximize global therapeutic value. The Clinical Study Planner partners with the Resource Forecasting Group to ensure optimized planning of resources and budget.
Own the development of and the implementation of high-quality, realistic, cross-functional, global clinical trial timelines, from design through final study reporting.
Lead, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate.
Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (i.e. via monthly RAP, annual LRS, quarterly LE, etc.)
Maintain accuracy of clinical study timeline information in Amgen data control systems (e.g. Planisware PPM), through conducting integrity checks and data issue resolution on a routine basis for assigned study timelines.
Partner with Resource Forecasting Group staff to support optimized planning of resources and budget.
Communicate information on clinical trial status, changes, and issues to partners, and confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines.
Increase the efficiency of trial operations through the sharing of cross-program knowledge and identification of standard methodologies leading to standardization across the organization.
Build scenario options in support of decision-making for operational or strategic direction.
Participate in or lead process improvement initiatives as assigned.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The research professional we seek is a leader with these qualifications.
Doctorate degree OR
Masters degree and 3 years of Clinical experience OR
Bachelors degree and 5 years of Clinical experience OR
Associates degree and 10 years of Clinical experience OR
High school diploma / GED and 12 years of Clinical experience
BA/BS/BSc in the sciences or RN
5+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical product development (clinical research or clinical operations experience acquired at a biotech, pharmaceutical or CRO company)
Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory
Project management tools and processes (e.g. MS Project, Planisware, PowerPoint) and strong digital literacy, including word processing, presentation, and spreadsheet applications
Experience with resource capacity planning tools and methodologies
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. 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.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.