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For your reference, we have included the original job posting below.
Clinical Data Management Systems Manager - Electronic Trial Operations
Job Number:
41708844
Company Name:
Amgen
Job Location:
South San Francisco, CA US
Job Categories:
Clerical & Administrative Research
Clinical Data Management Systems Manager - Electronic Trial Operations
The Clinical Data Management Systems Manager (Electronic Trial Operations) will work with a cross functional team of Clinical, Biostatistical, Supply Chain and Data Management representatives to support the design, implementation and maintenance of outsourced Interactive Voice Response (IVR) / Interactive Web Response (IWR) solutions for a clinical trial. The individual within this position will provide project management and technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations as well as Amgen policies, procedures and guidelines. The individual will also be responsible for the management, support and implementation of special projects / initiatives associated with Clinical Data Management.
This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site.
Key Responsibilities include:
Gather clinical and technical requirements into a clear and concise specification document
Facilitate/lead technical requirements meetings
Review and approve technical documents
Provide feedback on clinical protocols as it relates to electronic solutions
Implement and manage risk mitigation plans and activities
Manage project related timelines and associated activities
Identify and track project-related issues to resolution
Represent function within global task force/initiatives, as required
Basic Qualifications Doctorate degree OR Master's degree & 3 years of directly related experience OR Bachelor's degree & 5 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
Preferred Qualifications Bachelors degree in life science, computer science, business administration or related discipline
Successful delivery and track record performing and leading a team in a customer facing mission and representing and ensuring enterprise class technical service delivery
4+ years of experience in a client facing technical role within clinical data management, clinical development, or IS/IT
3 or more years experience in managing projects from inception through close-out
Previous experience working in a global environment
Previous Data Manager or study management related experience
Superior partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements
Work experience implementing clinical technologies such as IVRS/IWRS, IWT, CTMS, ePRO, EDC or other related technology in the pharmaceutical/biotechnology industry strongly preferred
Experience and ability creating and effectively presenting concepts and materials to senior and executive levels
Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
Candidates should demonstrate excellent project management and broad technical understanding, attention to detail, and excellent communication and documentation skills
Excellent time management and organization skills required
Must have sound problem resolution, judgment, and decision-making abilities
Must be able to work well in a global team-based matrix environment with minimal supervision
Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives
