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Clinical Systems & Analytical Reporting Manager

US - California - Thousand Oaks - Field/Remote

Career Category

Clinical

Job Description

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.

Clinical Systems & Analytical Reporting Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for assisting with technology implementation and study deliverables tasks. The successful candidate will have a background in clinical application technologies and be a strong leader with demonstrated ability to influence stakeholders, to engage cross-departmentally, and to partner with the vendor to ensure delivery of services. The candidate should be technologist with a desire to learn and adapt to a changing technology ecosystem.

Responsibilities include, but are not limited to, the following:

  • Provide technical and business process input / expertise on new and emerging technologies/vendors for clinical trial execution.
  • Serve as the technical liaison with study teams to gather/review business requirements.
  • Assist with the implementation of new features and keep up to date on application releases.
  • Assist with the evaluation of configuration settings and permissions for the application.
  • Develop integration specifications between applications
  • Deliver study specific tasks for study milestones (as needed).
  • Facilitate rapid issue resolution and keep stakeholders informed.
  • Partner with the vendor for the development of customized scripts, reports, datasets, or other solutions to support critical business processes.
  • Build effective relationships and partnerships within Global Development Operations (GDO), IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, Functional Service Provider (FSP) and EDC vendors.
  • Lead or contribute to system related or process improvement initiatives at the departmental, cross-departmental, or wider Programming, Analytics & Solutions organization.
  • Ensure documentation is consistent with …
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Job Profile

Regions

North America

Countries

United States

Restrictions

Field/Remote Hybrid

Benefits/Perks

Annual bonus program Career development Career development opportunities Career transformation Collaborative culture Competitive benefits Comprehensive employee benefits Comprehensive employee benefits package Discretionary annual bonus Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Hybrid work Innovative environment Life and Disability insurance Professional and personal growth Retirement and Savings Plan Stock-based long-term incentives Time-off plans Total Rewards Plan Welfare plans

Tasks
  • Assist with technology implementation
  • Data Management
  • Facilitate issue resolution
  • Issue resolution
  • Lead process improvement initiatives
  • Partner with vendors
  • Process Improvement
  • Study design
Skills

Analytical Analytics Audit Preparation Automation Best Practices Biopharmaceutical BioTech Biotechnology Business administration Business Requirements Clinical operations Clinical Research Clinical trial execution Clinical trials Compliance Computer Science Cross-departmental collaboration Data analysis Data Management Data Sharing Detail oriented Development Documentation Drug Development Execution FDA FDA regulations GCP Good clinical practices Industry knowledge Inflammation Insurance International regulatory requirements Issue Resolution IVR Life sciences Management Matrix Environment Negotiation Oncology Operations Organization Pharmaceutical Process Improvement Product Development Programming Project Management Quality Quality Assurance Rare Disease Research Safety Sales SAS Site Management SOPS SQL Stakeholder engagement Statistical Programming Study Design Teams Technology Implementation Therapeutic Areas

Experience

3 years

Education

Associates Bachelor's Bachelor's degree Degree DO Doctorate Doctorate degree GED High School High school diploma High school diploma/GED Life Sciences Master's Master's degree

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9