Amgen CDM Systems Manager- Clinical 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 Global Study Operations (GSO) Data Management Systems Manager will serve as an Amgen Global Librarian. This role will collaborate with Clinical Study Teams to develop Rave Clinical Trial Databases and drive Standards adherence. This role is also responsible for helping to maintain our Global library of standard structures and edit checks and will work closely with our Governance team to seek approval for new structures and changes to existing Standards.
Partner effectively with other Data Management roles and cross functional leads (e.g. Lead Data Manager, Data Element Standards Governance, Study Designer, Technical Designer to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. Also serve as Subject Matter Expert (SME) representing Global Library service remits in support of key process transformation projects, functional governance groups, and/or cross functional Projects.
Consultation on trial design to align to protocol, Standard Library usage and builds using Rave Architect Loader
Support of updates to the Clinical Trail during the maintenance and adherence to established Standards
Work collaboratively with multiple roles at the Functional Service Providers (FSP)
Serve as a Amgen Global Librarian within the Clinical Study Design & Programming group
Accountable for quality delivery and competencies within the Global Library service area
Partner with FSP Staff in maintaining consistent compliance to established Amgen processes and best practices
Membership of Standards Governance and Advisory Groups
Lead or contribute to key or interdepartmental initiatives / projects with particular focus in Standards or process improvements
Serve as the document author for process Standard Operating Procedures (SOP) or manuals and the corresponding companion guides and tools (e.g. templates, checklists etc)
Facilitate rapid issue resolution through others
Assist in audit preparation and responding to audit findings (internal or external)
Act as process SME and provide support to internal staff or providers
Work within a high-quality, high-availability technical service area within the clinical trial conduct space
Master's degree and 3 years of biopharmaceutical clinical research experience
Bachelor's degree and 5 years of biopharmaceutical clinical research experience
Associate's degree and 10 years of biopharmaceutical clinical research experience
High school diploma / GED and 12 years of biopharmaceutical clinical research experience
Bachelor degree or equivalent in life science, computer science, business administration or related discipline
Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research
Proven experience with Medidata Rave and the Architect module
Proven experience in Standards as related to development of Clinical Trial Databases
Experience in partnering with specific operational teams or external staff (FSP)
Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams
Experience and ability to create and effectively presenting concepts and materials to senior management levels
Project management and technical expertise, attention to detail, and excellent documentation and communication skills
Excellent time management and organization skills
Sound problem resolution, judgment, and decision-making abilities
Able to work well in a global team-based matrix environment with minimal supervision
Working knowledge of industry standards such as CDISC, SDTM, CDASH and other standards initiatives
Knowledgeable in Good Clinical Practices, and Global Regulatory regulations
Proven capability of overseeing and effective partnership with service delivery partners in delivering DM systems support or study deliverables
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.