Amgen CDM Systems Manager in Thousand Oaks, California

The Clinical Data Management (CDM) Systems Manager will work with a cross-functional team of internal stakeholders (including but not limited to Clinical study teams and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The CDM Systems Manager will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Responsibilities:

  • Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts

  • Design and oversee the development of study-specific IRT 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

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of IRT experience

OR

Bachelor's Degree and 5 years of IRT experience

OR

Associate's degree and 10 years of IRT experience

OR

High school diploma/GED and 12 years of IRT experience

Preferred Qualifications:

  • 5+ years of IRT 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 IRT 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 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.