Clinical IT

  • location: Exton, PA
  • type: Permanent
  • salary: $120,000 - $130,000 per year

job description

Clinical IT

Job Title: Laboratory Systems Manager

Position Description

  • The Laboratory Systems Manager will be responsible for overseeing the development, implementation and support of laboratory automation, data acquisition, and troubleshooting for Analytical Services and support the roll out of systems to other sites as necessary.
  • This person will create business plans working with the IT Project Manager to support system strategies defined by Analytical Services.
  • The Manager will work closely with IT, QA, Lab Metrology and Lab Operations globally.
Position Responsibilities

  • Collaborate with Analytical Services Management team on key business needs
  • Provide direction, support and leadership to IT Lab team
  • Collaborate with IT Project Manager to ensure system needs within Analytical Services are communicated and implemented including the development and management of strategies and project plans to support:

    o ensuring infrastructure is in place at site laboratories to support the roll out of major key initiatives for lab automation and compliance

    o the management of a global team for the evaluation and implementation of a global laboratory information management system

    o the management of the program for electronic laboratory notebook at required sites
  • Review/approve IQs, OQs, PQs, and validation protocols as necessary
  • Review and approve documents such as laboratory investigations, work instructions, SOP's, etc., as assigned
  • Research and recommend upgrades/new software and systems to increase compliance and efficiency in Analytical Services
  • Ensure that new systems and software are properly integrated with existing processes and capabilities
  • Assist and participate in audits
  • Work with the IT Project Manager to provide budgeting information for new systems, service agreements, software upgrades, etc
  • Keep current with new technologies and cGMP regulations.
  • Implement continuous improvement/lean activities
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance.
Position Requirements

  • Education: Bachelor's in Computer Science/Information Technology or related field
  • Experience: 5-8 years of experience
  • Experience with implementing and managing laboratory computer systems
  • Knowledge of cGMP regulations, and validating cGMP computer systems
  • Experience with laboratory systems such as Waters Empower
  • Knowledge of the software development lifecycle
  • Proven track record of collaboration and leadership
  • Excellent communication and presentation skills
  • Strong interpersonal skills with the ability to communicate effectively at all levels
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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