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Listed below are the top 10 out of 104 listings that are in the same industry and location as the job you were looking for. To see more than 10 listings, click here to search similar jobs in South San Francisco, CA


 
 

May 19

Amgen - South San Francisco, CA US

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Jan 13

Amgen - South San Francisco, CA US

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Apr 26

Randstad - Oakland, CA US

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JC Johnson Investment Corp - Silicon Valley, CA US

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To view more listings click here to search Administrative Jobs in South San Francisco, CA


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

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