Manager, CSAR - Global Library

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.

Manager, CSAR - Global Library

What you will do

The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology.

The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change.

The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)..

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

Support of clinical trial platform technologies

Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.

Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems

Coordinating and providing programming support to Clinical Study Teams

Maintaining standard business processes within GDO to ensure compliance to regulatory bodies

Acting as a technical point of contact for systems deliverables on defined programs

Providing technical and business process input / expertise on new and emerging technologies

Develop, review and implement policies, SOPs and associated documents

Assist in preparing for and responding to audit findings (internal or external).

What we expect of you

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

Basic Qualifications:

Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR)

Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR)

Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience

Preferred Qualifications:

Advanced degree in life science, computer science, math, statistics, business administration or related field

Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena

General project management and planning experience

Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)

Knowledge:

Good Clinical Practice

Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking.

Drug development and clinical trials processes

Data management processes

Programming of clinical trial databases and applications

Systems development lifecycle

Programming Languages

Project planning and management

Quality management

Regulatory filings and inspections

Understanding of CDISC and SDTM

Process improvement methodologies

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, 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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

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