The GSO DM Systems Manager will serve as the Operational Lead for the Electronic Data Acquisition (EDA) and Electronic Data Interchange (EDI) operational areas. This role oversees a team that is responsible for importing data for Amgen's clinical studies from a variety of external sources including central lab and imaging vendors. The role also oversees Amgen's execution of database snapshots from Amgen's Rave clinical trials database for use by Biostatistics. The successful candidate will be adept at managing a high-quality, high-availability technical service area within the clinical trial conduct space.
The primary deliverables for the EDA/EDI operational area include supporting electronic data acquisitions, database snapshots, medical coding extractions, securing potential unbinding/restricted clinical data, as well as providing datasets or listings for audit support. The operational lead will be accountable for the service delivery oversight and process compliance supported by a Functional Service Providers (FSP).
The position is expected to partner effectively with other DM Systems Leads and cross functional leads (e.g. Data Element Standards Governance, Technical Services, BSM, IS) to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. Also serve as key process expert representing EDA/EDI service remits in support of key process transformation projects, functional governance groups, and/or cross functional systems integrations.
* Serves as the Operational Lead for the EDA/EDI operational area within the Clinical Study Design & Programming group.
* Accountable for quality delivery and competencies within the EDA/EDI service area.
* Partner with FSP Operational Lead in maintaining consistent compliance to established Amgen processes and best practices for the FSP deliverables.
* Partner with FSP Operational Lead in managing CAPA related to the EDA/EDI quality delivery or compliance issues.
* Lead or contribute to key or interdepartmental initiatives / projects with particular focus in system or process improvements.
* Serves 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, Technical Services) to address potential systematic or technical vendor 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 EDA or EDI staff members.
Master's Degree and 3 years of Clinical experience
Bachelor's Degree and 5 years of Clinical experience
Associate's degree and 10 years of Clinical experience
High school diploma/GED and 12 years of Clinical experience
3+ years of experience in Base / Advance SAS programming.
3+ years of experience in a technical role within clinical data management, clinical development, or IS/IT
Experience in leading and overseeing a specific operational team or external vendors (internal team, FSP, CRO, central labs, imaging vendors etc).
Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams
Experience and ability creating and effectively presenting concepts and materials to senior management levels
Candidates will demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills
Has operational experience in handling potential unbinding clinical data and file transfer technologies (MOVEit, box etc).
Excellent time management and organization skills
Will have sound problem resolution, judgment, and decision-making abilities
Will be able to work well in a global team-based matrix environment with minimal supervision
Working knowledge of industry standards such as CDISC LAB, CDASH and other standards initiatives desirable
Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
The manager will be a highly motivated and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will command respect from peers and with strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues. He or she will have extensive clinical trial technical experience and leadership expertise.
Proven capability of overseeing and effective partnership with external vendors or service delivery partners in delivering DM systems support or study deliverables.
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. imaging years for snapshots BACH_a33d1a governance
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