Amgen is seeking a Senior Manager Information Systems (IS)-Clinical Data Integrations and Analytics at its main headquarters in Thousand Oaks, CA to join the GDO (Global Development Operations) team and report to the Director & Global lead for Clinical Trial Design and Management IS services. Responsible for leading a multi-year strategic program to build Amgen's Clinical Data Repository and Risk Based Monitoring solution and own the service after it is delivered. Program's vision includes developing a state-of-the-art solution in partnership with Amgen's strategic partners to deliver a platform that includes a patient data repository, operational data repository, Clinical Trial operational analytics & reporting, Medical monitoring and support IS capabilities required for enabling Centralized monitoring/RBM - Risk Based Monitoring.
GDO is a critical business area with high impact on Amgen's Clinical Study Execution and Pipeline delivery. Technology plays a vital role in support of this business area. Through the strategic use of technology and information, this position will help create competitive advantages for Amgen with industry leading cycle times.
Travel: Domestic and international travel up to 25% might be essential.
Own and deliver Clinical Data Integrations and Analytics service, this includes developing vision, strategy and Service Roadmap, working closely with business and IS Sr. Management and frequently interacting with Executive leadership of the organization
Manage the execution of a varied portfolio of IS projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio
Manage "Run" and "Build" project portfolio, supporting systems compliance with GCP requirements
Shaping Amgen's future - Keep track of industry and technology trends, connect and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.
Ensure scalability, cost-effective design, development, and engineering in both short and long-term timeframes through the effective employment of various suppliers and enterprise COEs (e.g. Enterprise Architecture, Enterprise BI, Solution Developers etc.)
Effectively manage relationships with business partners, enterprise IS service partners, and vendors
Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional requirements - Develop System Requirements
Doctorate degree and 2 years of Information Systems experience
OR Master's degree and 6 years of Information Systems experience
OR Bachelor's degree and 8 years of Information Systems experience
OR Associate's degree and 10 years of Information Systems and/or experience
OR High school diploma / GED and 12 years of Information Systems experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Knowledge of the Clinical Trials domain and business functions - processes, tools, data standards, artifacts and systems (EDC, IVRS, PROs, CTMS, CDISC-SDTM etc.)
Experience in supporting regulated/validated systems and understanding of 21CFR Part 11 requirements)
Strong experience in methods and technologies to support Clinical System integrations (e.g. ETL- Informatica, Web Services/messaging, data mapping)
Good understanding of data modeling & data warehousing concepts, familiarity of analytics and visualization tools (e.g. Spotfire)
Experience with all phases of SDLC (Software Development Life Cycle) and use of Agile/SCRUM methodologies
Proven track record of managing project portfolio, financial management and project execution
Experience in identifying business opportunities and turning functional requirements into solutions that address difficult business challenges through the use of IS solution
Proven ability to work and lead in a dynamic environment with little supervision
Ability to combine strategic business and technical direction, and translate concepts into actionable implementation plans
The preferred candidate will have the combined qualities of a good salesman, a caring teacher or coach, an enthusiastic inventor, a careful analyst, and a knowledgeable engineer
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.
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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.