Clinical Data Manager (US-Remote)

Career Category

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 Data Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the Project Lead within Global Study Operations Data Management (GSO DM) and report to the Senior Manager-GSO Data Management. Amgen GSO-DM is strategically resourced with external vendor support through a functional service provider (FSP) model. The Data Manager taking this role will partner with cross functional study teams as well as the FSP to ensure product delivery of the Amgen Therapeutic Area portfolio.

Global Study Operations (GSO) – Data Management plans and implements the capture, cleaning and storage of all Amgen clinical study and trial management data.

Specific responsibilities include but are not limited to:

• Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
• Ensure that quality control checks are occurring such that quality databases are delivered.
• Develop and co-ordinate project level training for data management staff.
• Review and approve study specific training and lead vendor results and relationship at the project level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other …