Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist

Amgen • Thousand Oaks, CA

2d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Electronic Clinical Outcomes Assessments (eCOA) Technical Specialist What you will do Let’s do this. Let’s change the world. In this vital role you 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. Amgen eCOA Technical Specialists work with internal stakeholders and eCOA vendors to support the eCOA system delivery, maintenance and provide subject matter expertise for projects related to eCOA deployments.

Requirements

• Doctorate degree OR Master’s degree and 2 years of clinical experience OR Bachelor’s degree and 4 years of clinical experience OR Associate’s degree and 8 years of clinical experience
• High school diploma / GED and 10 years of clinical experience

Nice To Haves

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

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

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees