Amgen Clinical Study Planning Manager in Thousand Oaks, California
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The Clinical Study Planner drives 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.
This is a global role based in Global Development Operations (GDO).
Lead the development of and monitor the implementation of high-quality, realistic, cross-functional, global clinical trial timelines, from design through final study reporting, in Amgen's planning systems within specified deadlines
Manage, 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 (ie, via monthly RAP, annual LRP, 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 stakeholders, 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 best practices leading to standardization across the organization
Create scenario options in support of decision-making for operational or strategic direction
Participate in (or lead) process improvement initiatives as assigned
Master's degree and 3 years of clinical experience
Bachelor's degree and 5 years of clinical experience
Associate's degree and 10 years of clinical experience
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 obtained 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)
Strong computer literacy, including word processing, presentation, and spreadsheet applications
Experience with resource capacity planning tools and methodologies
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.