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• Post :- 17th Dec 2020

Job Title         Remote LIMS Project Manager
Location         Melville NY
Duration         12 months /Contract

JOB DESCRIPTION

 

Interview-Phone then skype
Visa-any

In this role, the LIMS Project Manager will be accountable for managing the end-to-end implementation and oversight of a Laboratory Information Management System validation project. Responsibilities to include the preparation and maintenance of the project plans, schedules, timelines and deliverables during the length of the project. The Project Manager will oversee the completion of the project tasks and participate in the initial analysis and estimation of time and resources and is accountable for adhering to target milestone and validation activities. The role of Project Manager will interact directly with the site resources, internal managers / lab managers, IT and other resources in efforts leading to the successful implementation of the LIMS technology.

 

Major Accountabilities

Day to day management of the project and commitments, including communications with Stakeholders, Business Leads, IT and responsible parties (i.e. software vendor) related to project status.

Ensure that the project remains on schedule, adheres to timelines, milestones met and is within allocated budget.

Coordinate and monitor project deliverables and progress through effective and clear communication and compile project status reports and other documentation as needed.

Create and maintain project plans as required. Ensure that users and project team member's roles and responsibilities defined. Ensure that user requirements, SDLC deliverables and approvals defined and documented for the project.

Manage the project’s cross-functional team in ensuring project completion and in compliance with the appropriate industry and regulatory standards, and Corporate Quality goals.

Set priorities for problem resolution and document delays and track issues encountered during the implementation phases of the LIMS project.

Communicate pertinent system information to site/project leadership when needed, identify, document and communicate the new site business requirements. Minimize and manage project scope creep.

Assist in working with the business and vendor to identify data needs in new LIMS system.

Assist in defining data migration requirements and in creating and maintaining SDLC documentation required for the LIMS project.

Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training activities.

Experience implementing a LIMS technology under a defined corporate and compliant methodology (i.e. Agile or Scrum)

As required, Laboratory Management may assign and require other duties and responsibilities not previously mentioned above.

Manage, edit and direct input to project deliverables (i.e. URS, UAT, FS, TM, CS, and OQ, PQ etc.) as applicable.

Oversee validation activities related to the project and support business buildouts and LIMS changes.

 

 

Skills:

Expert understanding of computer and application architecture, technology, and validation (CSV)

Work effectively in a team environment with ability to take upper management direction.

Accurately estimate project and task resource requirements.

Define and control project definition and scope.

Superior analytical ability and communication skills.

Ability to lead and be responsible for the productivity of others.

Self-starter. Asserts influence over events to achieve goals. Proactive.

Identify novel and unexpected ways of solving problems or improving products.

Strong problem analysis and problem-solving skills.

Ability to direct and counsel team members to improve project turnaround times on deliverables, as needed to keep project timelines in check.

Provide strategic direction to the Project Team based on combination of industry and technical knowledge.

Promote use of project management best practices.

 

Education:

Bachelor Degree in a related science discipline. A candidates combination of education and experience will be considered.

5+ years of Project Management, systems implementation and analysis experience in a GxP regulated environment.

Advanced knowledge of LIMS applications and procedures (Labware a strong plus).

5 Years of Project Management leading the implementation of LIMS project in the biotech, pharmaceutical or process industries - at least 3 years of recent experience.

Project lifecycle experience within the pharmaceutical, bioscience or process industries.

Extensive experience working with medium to large-scale scientific systems.

Strong scientific background with advance knowledge of laboratory workflows.

Hands on experience working within MS Project.

Excellent presentation and communications skills.

Advanced knowledge in implementing technology under a defined corporate and compliant methodology.