Job ID: R-90375 Location: Thousand Oaks, CA, US 91360
The Clinical Systems & Analytical Reporting (CSAR) manager will be accountable for critical site facing systems and processes. The CSAR Manager will own the Shared Investigator Portal (SIP) System and all the related integrations. The CSAR Manager will support Amgen's rollout of this tool to all clinical investigator sites across the globe. In addition, the CSAR Manager will also assist in managing Amgen's Clinical Trial Management System (CTMS) and its associated processes. The CSAR Manager will work with various Business Process Owners (BPO), Site Management, Data Management, Trial Master File (TMF), Study and Information Systems teams to deliver efficiencies in Study Start Up operations and Clinical Trial Management through innovation in system and processes.
Partner with Clinical Trial Management, Information Systems (IS), and SIP Vendor in executing the Amgen SIP Roadmap. Work with Business Process Owners and study teams in delivering efficiencies with Amgen's CTMS
Business System Owner for Amgen SIP and owning feature/configuration changes, and prioritization of requirements, configurations etc. Accountable to advance operational efficiency through new creative solutions, data integrations, and diligent vendor oversight
Subject Matter Expert (SME) for SIP & CTMS with respect to both hands-on technical and process
Point of Contact for IS and Business Stakeholders to support the elaboration of requirements for CTMS upgrades
Own incoming and outgoing integrations between SIP, CTMS, and other systems
Assist with any report generation / analysis on an as-required basis
Advise the Business Process Owners & Management on both technology and process
Support audits and CAPAs related to SIP & CTMS
Develop robust documentation approaches in partnership with IS to demonstrate strong validation controls
Participate in impact assessment discussions to navigate through various changes in SIP, CTMS or dependent systems
Serve as a Change Advisory Board/Emergency Change Advisory Board (CAB/ECAB) member for CTMS and SIP reviewing business impact
Doctorate degree OR Master's degree and 3 years of Scientific or Clinical experience OR Bachelor's degree and 5 years of Scientific or Clinical experience OR Associate's degree and 10 years of Scientific or Clinical experience OR High school diploma / GED and 12 years of Scientific or Clinical experience
5+ years work experience in life science or related field
Experience in owning and supporting systems and processes related to clinical trial management
Ability to understand business processes and clinical systems, and influence key stakeholders including BPOs and study teams in new ways of thinking to improve system and process efficiencies
Exemplary customer service skills, as demonstrated in being able to pivot quickly to emerging or changing business requirements while leveraging business relationships to maximize product delivery
Excellent communication and listening skills to stakeholders, technical community, and fellow business and technical peers in order to make thoughtful decisions, influence directional positions, and address risks
Be highly self-driven with a strong work ethic focused on results and high-quality outputs
Experience in influencing system design and requirement decisions with a good understanding of the business process and system capability
Experience with internal and/or external quality and compliance related audits
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.
If 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.