This position can be located in Thousand Oaks or San Francisco, CA
The Clinical Data Management (CDM) Systems Manager will work with cross-functional teams responsible for executing Amgen clinical trials, as well as, Interactive Voice/Web Response Systems (IVRS) supplier and Project Managers to support the design, implementation and maintenance of outsourced IVRS systems. The role provides technical and project management oversight to ensure that the system designed for the study adheres to the study's protocol, industry regulations / best practices, and Amgen policies, procedures and guidelines.
Lead and facilitate system requirements gathering meetings with clinical study teams and IVRS design PM
Design and oversee the development of study-specific IVRS technical documents
Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM
Identify and track study-related technical issues to resolution
Closely manage project-related timelines and associated activities
Master's Degree & 3 years of Clinical experience
Bachelor's Degree & 5 years of Clinical experience
Associate's degree & 10 years of Clinical experience
High school diploma/GED & 12 years of Clinical experience
Bachelor's Degree in life science, computer science, engineering, business or related discipline
4+ years of experience in clinical operations, clinical supply chain or clinical systems management
Experience implementing clinical systems, such as IVRS and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Vendor management experience
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision
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.