Project Manager

Highly Competitive Salary
  1. Permanent
  2. Laboratory Technician
  3. United States
Santa Monica, USA
Posting date: 19 Jun 2020

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.