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