Study Liaison Senior Associate

Study Liaison Senior Associate

Lets do this. Lets change the world. In this vital role you will accountable for the development of GPS strategy for safety-related organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards.

Accountable for the review, approval, and execution of GPS safety data collection strategy across clinical programs (e.g. interventional, observational research, non-Amgen sponsored clinical research, post-trial access, expanded access, etc.).

Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products.

The Senior Associate works on projects and processes that ensure the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical trial activities to ensure Amgen remains aligned with global safety legislation and requirements.

Responsibilities include:

• Aids in various administrative tasks regarding project activities and schedules.
• Keeps information up to date including schedules and the project information in appropriate applications.
• Perform tasks with minimal direction, in addition to working on teams to accomplish tasks.
• Various administrative tasks regarding project activities and schedules and posting items to project folders.
• Coordination with the project team and project manager.
• Provide technical support to ensure the execution of the groups objectives.
• Provide assistance and input to the development of protocols, contracts, safety management plans, and investigative site study guidance documents
• Supports clinical reconciliation activities and vendor oversight to ensure reporting of all reportable safety event data within teams remit.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications.

• Demonstrates analytical skills to solve day-to-day problems
• Applies a methodical approach to completing all tasks
• Demonstrates solid written and oral communication skills
• Demonstrates Amgen Values and clearly presents information (spoken or written)
• Communicates at various organizational levels and listens actively
• Applies a consistent approach to planning and organizing tasks
• Demonstrates ability to perform accurate and detailed work
• Demonstrates excellent ability to learn quickly and understand/adapt quickly to new systems, processes, and tools
• Organized, reliable, and responsive.

Basic Qualifications:

Masters degree

OR

Bachelors degree and 2 years of Pharmaceutical Industry experience

OR

Associates degree and 6 years of Pharmaceutical Industry experience

High school diploma / GED and 8 years of Pharmaceutical Industry experience

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.