Amgen

CDM Systems Mgr

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Mar 13, 2019
Ref
R-70208
Required Education
Doctorate/PHD/MD
Position Type
Full time
The GSO DM Systems Manager will serve as the Study Design Operation Lead and will be responsible for ensuring that we deliver database builds and maintenance activities in support of our Clinical Study Teams. The Manager oversees a team that is responsible for building and maintaining our Rave Clinical Trials Databases and programming Edit Checks based on the Data Management Plan.

The Manager will be adept at managing a high-quality, high-availability technical service area within the clinical trial conduct space.

The primary deliverables for the Study Design Operational area include supporting Rave Database builds, Maintenance activities, Edit check and Custom Function programming, Proof of concept builds to support large scale projects. The operational lead will be accountable for the service delivery oversight and process compliance supported by a Functional Service Providers (FSP).

The Manager will partner effectively with other DM Systems Leads and cross functional leads (e.g. Data Element Standards Governance) to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. Also will serve as key process expert representing the Study Design service remit in support of key process transformation projects, functional governance groups, and/or cross functional systems integrations.

Responsibilities:
• Serve as the Operational Lead for the Study Design operational area within the Clinical Systems and Analytical Reporting.
• Accountable for quality delivery (Quality Oversight Plan) and competencies within the Study Design service area.
• Partner with FSP Operational Leads in maintaining consistent compliance to established Amgen processes and best practices for the FSP deliverables.
• Partner with FSP Operational Leads in managing CAPA's related to the Study Design quality delivery or compliance issues.
• Lead or contribute to key or interdepartmental initiatives / projects with particular focus in system or process improvements.
• Serve as the document author for process SOP or manuals and owner for the corresponding companion guides and tools (e.g. templates, checklists etc).
• Facilitate rapid issue resolution through others (internal forces and FSP).
• Effectively partner with cross functional support groups (i.e. Amgen IS, EDC Operations) to address potential systematic or technical quality issues.
• Assist in audit preparation and responding to audit findings (internal or external).
• Act as process SME and provide support to internal staff or providers.
• Authorize appropriate systems access requests for FSP Study Design and Custom Function staff members.

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Clinical experience

OR

Bachelor's Degree and 5 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:

Bachelor's Degree in life science, computer science, engineering, business or related discipline

4+ years of experience in clinical development

Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry

Knowledgeable in Good Clinical Practices, and FDA regulations necessary

Project management and technical expertise, attention to detail, and excellent documentation and communication skills

PMP

Previous vendor management experience

Excellent time management and organization skills

Have sound problem resolution, judgment, and decision-making abilities

Be able to work well in a team-based environment with minimal supervision

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.

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