Amgen Job Description The position will work with a cross functional team of internal stakeholders (including Clinical, Biostatistical and Supply Chain representatives) and external stakeholders (IVRS provider representatives) to support the design, impl

Description

Amgen Job Description The position will work with a cross functional team of internal stakeholders (including Clinical, Biostatistical and Supply Chain representatives) and external stakeholders (IVRS provider representatives) to support the design, implementation and maintenance of outsourced electronic solutions to support a clinical trial. The individual within this role will provide technical oversight to ensure that the study specific electronic solution adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines

Key Responsibilities include: 
• Lead study level system requirements meetings with internal and external clients 
• Design and oversee the development of study specific technical documents 
• Document possible risk and implement mitigation plans 
• Manage project related timelines and associated activities 
• Identify and track study-related technical issues to resolution 
• Provide a supportive framework for continuous process and quality improvements 
Basic Qualifications Doctorate Degree 
OR 
Master's Degree & 3 years of Clinical experience 
OR 
Bachelor's Degree & 5 years of Clinical experience 
OR 
Associate's degree & 10 years of Clinical experience 
OR 
High school diploma/GED & 12 years of Clinical experience 
Preferred Qualifications • Bachelor's Degree in life science, computer science, engineering, business or related discipline 
• 4 or more years of experience in clinical operations, clinical development or clinical quality assurance 
• Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred 
• Knowledgeable in Good Clinical Practices, and FDA regulations necessary 
• Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills 
• Candidates must have previous vendor/client management experience
• 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 team-based environment with minimal supervision 
Additional Info Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Nr of positions available : 1

Research Fields

Medical sciences

Career Stage

Early stage researcher or 0-4 yrs (Post graduate) 
Experienced researcher or 4-10 yrs (Post-Doc) 
More Experienced researcher or >10 yrs (Senior) 

Research Profiles

Not defined

Comment/web site for additional job details

US - CA - South San Francisco