Project Manager

Proclinical is currently recruiting for a LIMS Project Manager - Research with a pharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

• Develop specification requirements for all potential users and ensure the LIMS can meet these expectations
• Coordinate writing of project-related SOPs, as necessary
• Create and maintain an overall project plan
• Overall responsibility for satisfactory process and communication for the LIMS project
• Create a LIMS Project Working Group, comprised of members with adequate knowledge and training to ensure project success
• Ensure project meets all regulatory requirements for specimen storage, chain of custody and transfer for FDA and EAU submission, including USFDA part 11 compliance
• Ensure data storage meets all regulatory compliance, including HIPAA
• Communicate project information to interested parties as assigned
• Create and distribute LIMS project meeting minutes
• Develop and track costs, resources and other financial information
• Manage the contract and deliverables, and work with LIMS external vendor to ensure satisfactory process and fiduciary responsibility
• Manage and ensure proper documentation of LIMS training
• Communicate launch plan with affected parties and ensure launch readiness
• Perform and coordinate LIMS testing, validation and documentation
• Ensure IQ, OQ and PQ of any supplementary instrumentation
• Manage access and levels of permission for LIMS users
• Become a LIMS superuser and assist in training
• Work with Bioinformatics to coordinate data links and restrict data availability as necessary
• Coordinate and attend LIMS project working group meetings as needed
• Perform cross functional communications to drive the LIMS project

Skills and Requirements:

• Bachelor's degree (preferred but not required)
• Experience with LIMS implementation in a regulated laboratory environment
• Knowledge and experience working in a GxP environment, preferred
• 2-3 years of industry project management experience or equivalent
• Basic understanding of IT systems infrastructure
• Excellent interpersonal, verbal and written communication skills
• Basic understanding of biospecimen storage and logistics in a regulated laboratory environment

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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