Project Manager

Proclinical is currently recruiting for a Project Manager with a pharmaceutical company located in Santa Monica, CA. A successful candidate will have expert experience with LIMS implementation in a regulated laboratory environment and experience working in a GxP environment.

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
• Escalate any stalls or roadblocks
• Create, track and measure project milestones
• Obtain complementary documents and associated approvals as required for each step in the project, such as validation scripts, specification documents, SOP writing, training sessions, etc.
• Maintain project documentation
• Reconcile external vendor deliverables as needed for the project
• Understand project-specific deliverables (eg, sandbox environment testing, departmental specifications) and ensure timely completion of project activities

Skills and Requirements:

• Bachelor's degree preferred
• 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
• Working knowledge of Microsoft Office, Excel, Laboratory Information Management Systems; ability to navigate and learn systems (eg, central laboratory system)

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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