Careers

Pacific Biomarkers, a clinical laboratory specializing in testing for pharmaceutical clinical trials and diagnostic research and development, has an opening for Manager of Information Technology. The MIT will be a hands-on leader for the team responsible for the IT Infrastructure and the SDLC. This position requires software development experience to include programming and validation. The ideal candidate will have experience validating systems in a “GXP” environment with an understanding of the regulatory requirements and the associated documentation requirements.

Experience and Qualifications

• Must have professional experience working as a Project Manager for at least six years, preferably with clinical trial operations
• Must possess good written and interpersonal communication skills and be able to work effectively in a team
• Must be extremely detail oriented, well organized and committed to maintaining rigorous documentation standards
• Experience with Microsoft Office (especially Word, Powerpoint and Excel)
• Previous experience in a clinical or research laboratory and familiarity with Laboratory Information Systems a plus
• Lead or supervisory experience desirable

Education:

• Bachelor’s degree required; life or medical sciences preferred
• Certification in project management and clinical trials desirable

Position Responsibilities:

• Responsible for the successful conduct of assigned projects including the on time provision of client deliverables
• Communicate the needs of the client or study to the appropriate PBI department and serve as liaison between client and PBI
• Prepare study plans, central lab materials and documents, and sample analysis reports
• Project and monitor study revenue and other study metrics

Pacific Biomarkers, a clinical laboratory specializing in testing for pharmaceutical clinical trials and diagnostic research and development, has an opening for Manager of Information Technology. The MIT will be a hands-on leader for the team responsible for the IT Infrastructure and the SDLC. This position requires software development experience to include programming and validation. The ideal candidate will have experience validating systems in a “GXP” environment with an understanding of the regulatory requirements and the associated documentation requirements.

Experience and Qualifications

• 5+ years experience in all phases of the Software Development Life Cycle (SDLC)
• Programming/database experience in some or all of the following required: C#, Visual Basic, Revelation/Open Insight database/RBasic, MS SQL Server, MS .Net Framework; also helpful: Web application development
• Validation in GXP environment including all associated documentation; understanding of the requirements and guidelines for 21 CFR Part 11
• Experience in systems administration of MS Windows network; network hardware and troubleshooting; workstation hardware/software; user helpdesk
• Working knowledge of MS Office Suite with programming experience in Excel, Access
• Must possess good communication skills and be able to work effectively in a team; demonstrated ability to lead staff is required
• Familiarity with Laboratory Information Systems and laboratory instrumentation interfaces preferred

Education:

• BS in computer science/engineering or related required
• Network certification preferred

Position Responsibilities:

• Provide leadership for the Information Technology department; responsible for network infrastructure and all phases of the SDLC
• Programming and network/helpdesk support as needed
• Responsible for ensuring that information systems meet regulatory requirements
• Play a key role in project request prioritization and tracking of projects/strategic initiatives