Senior Manager - Clinical Data Management

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.

Senior Manager - Clinical Data Management

What you will do

Let’s do this. Let’s change the world. In this vital role you will partner with cross functional study team, as well as, FSP to ensure delivery of the Amgen TA portfolio. You will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, Global Study Operations (GSO). You will focus on timely quality delivery, as well as, consistency across the Data Management (DM) components.

Responsibilities

• Through cross-portfolio review, ensure delivery of all timelines and deliverables for the GSO-DM components

• Plan and lead all aspects of GSO-DM activities for various TA products, projects, vendors or services

• Risk Management

• Resource Management

• Strategic Portfolio Management

• Quality Management

• Stakeholder Management

• Responsible for staff recruitment, management and development, as well as, staff performance in-line with Amgen’s process

• Provide mentorship to staff and lead by example

• Act as an SME across projects to ensure best practices in all GSO-DM processes and to ensure consistency within and across programs

• Identify process improvement opportunities and drive forward

• Evaluate the resourcing levels in partnership with FSP to ensure appropriate distribution and accountability for delivery of the portfolio demands.

• Ensure GSO-DM processes are appropriately developed and are clearly communicated, with an eye toward continuous improvement of performance measures

• Cultivate and maintain effective partnerships and knowledge transfers across Amgen.

• Stay abreast of industry developments in the Data Management field and apply to appropriate systems or processes

• Define and contribute in the process and/or technical implementation of DM and the wider GSO Strategies

• Lead and/or participate in cross functional key projects and/or working groups

• Develop, review and implement policies, SOPs and associated documents affecting DM globally

• Provide technical and business process input / expertise and leadership on process improvement activities, new and emerging technologies

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of clinical data experience OR

• Master’s degree and 4 years of clinical data experience OR

• Bachelor’s degree and 6 years of clinical data experience OR

• Associate’s degree and 10 years of clinical data experience OR

• High school diploma / GED and 12 years of clinical data experience

Preferred Qualifications:

• Master’s degree or equivalent in life science, computer science, business administration or related subject area

• 10+ years experience in data management in the Pharmaceutical or Biotech arena

• 3+ years experience in a global organization

• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc)

What you can expect of us

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,