Project Manager job in Santa Monica, USA

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First Name*

Last Name*

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Phone Number*

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Job type: Permanent

Discipline: Biological Sciences, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

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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