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.
Lead Data Manager GSO - Data Management
Let’s do this. Let’s change the world. In this vital role you will partner with cross functional study team to deliver accurate and reliable data. This individual will ensure a focus on timely quality delivery as well as consistency across the Data Management components. All results will be achieved in a manner that embodies Amgen culture and values, collaboration and partnership, ethics, and staff development.
Delivering data for assigned studies and giving to clinical study planning.
Ensuring data quality meets expectations and that DM deliverables are to agreed timelines.
Communicating within assigned study teams regarding DM activities.
Providing DM documents for assigned studies as defined by DM processes.
Ensuring that DM procedures and processes are adhered to.
Study level planning and coordination of DM tasks.
Development, review, and approval of required DM study-related documents.
Set up and maintenance of study-specific project plans.
Independently manage end-to-end delivery of data management services including study start-up, conduct, and close-out of assigned studies.
Database development and maintenance/updates through Change Control process, including both CTDB and external vendor data components.
Tracking and review of study status/metrics.
Ongoing review of data quality from vendors.
Maintain inspection readiness and a contemporaneous Trial Master File at all times.
Manage vendor deliverables and relationships at the study level.
Communication and escalation of day-to-day issues and risks including study status, timelines, data quality, resourcing, etc.
Review of study level documents from other functions that require DM input.
Respond to study-specific data questions/findings from other functions.
Serve as the main data management point of contact for clinical and data management study team members.
May oversee staff.
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Master’s degree and 4 to 6 years of [Job Code’s Discipline and/or Sub-Discipline] experience OR
Bachelor’s degree and 6 to 8 years of [Job Code’s Discipline and/or Sub-Discipline] experience OR
Diploma and 10 to 12 years of [Job Code’s Discipline and/or Sub-Discipline] experience
Preferred Qualifications:
Knowledge and understanding of data management processes
Proficiency in project planning and management
Knowledge of drug development and clinical trials processes
Knowledge of Good Clinical Practice
Experience of working in several therapeutic areas
Quality management
Experience of vendor oversight
Experience of regulatory filings and inspections
Teamwork
Attention to detail
Written and verbal communication
Delivery Focus
Problem solving
Initiative
Relationship building
Project management
Leadership skills
Strategic thinking
Prioritization
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, we’ll 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.
for a career that defies creativity
Objects in your future are closer than they appear. Join us.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.