Amgen

CDM Systems Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 19, 2019
Ref
R-72032
Required Education
High School or equivalent
Position Type
Full time

The electronic Clinical Outcomes Assessments (eCOA) Technical Specialist will work with a cross functional team of Clinical representatives to support the design, implementation and maintenance of outsourced eCOA systems to support clinical trials. The individual within this role will provide technical oversight to ensure that the study specific eCOA systems adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Responsibilities:

  • Accountable for quality delivery and competencies within the eCOA service area
  • Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
  • Assist in the design and development of study specific technical documents
  • Support the internal team in managing project related timelines and associated activities
  • Partner with data management (DM) to define the requirements for data transfers
  • Work with external resources to manage the creation and execution of user acceptance tests
  • Identify and track study-related technical issues to resolution
  • Provide a supportive framework for continuous process and quality improvements

 


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Clinical experience

OR

Bachelor's Degree and 5 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:

Bachelor's Degree in life science, computer science, engineering, business or related discipline

4+ years of experience in clinical development

Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry

Knowledgeable in Good Clinical Practices, and FDA regulations necessary

Project management and technical expertise, attention to detail, and excellent documentation and communication skills

PMP

Previous vendor management experience

Excellent time management and organization skills

Have sound problem resolution, judgment, and decision-making abilities

Be able to work well in a team-based environment with minimal supervision

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.