16 days old

Laboratory Project Manager

CTI Clinical Trial Services, Inc.
Cincinnati, Ohio
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Responsible for management and oversight of assigned laboratory projects to ensure client’s goals of time, cost, and quality performance are met. The LPM is expected to perform most tasks independently, with the support and guidance of the Director and/or senior leadership of CTI Laboratories.  The LPM will ensure successful project execution and support other laboratory functional team members’ management of daily operations. 

  • Plan, implement, evaluate, and complete execution of assigned laboratory projects; may function as a global lead, where applicable 

  • Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned laboratory projects 

  • Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and laboratory procedures 

  • Provide management of the full scope of laboratory projects including global projects from start-up through closeout; provide oversight of functionally assigned teams members on laboratory projects; manage multiple projects simultaneously 

  • Work closely with the CTI Clinical Project Manager and Team members on full service projects 

  • Provide coordination of a laboratory project including organization, implementation, and management of scoped activities 

  • Prepare or provide oversight to the development of project plans and timelines; work with laboratory leadership and/or line manager to provide effective solutions to challenges that arise during the laboratory project 

  • Participate in or provide oversight and guidance in the development of project required deliverables 

  • Serve as Global Project Manager and/or client contact at project operational level 

  • Provide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations 

  • Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all project team members to enable accurate reporting to clients and CTI executive management 

  • Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues 

  • Ensure that assigned project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the project 

  • In conjunction with the client and cross-functional CTI laboratory departments, create the Laboratory Specifications Worksheet based upon contracted services at the initiation of a new project, and maintain and update the document as needed throughout the lifecycle of the project 

  • Build project-specific laboratory database in lab information management system (LIMS) at initiation of a new project; maintain and update the database as needed throughout the lifecycle of the project.  

  • Develop project-specific site tools such as the Laboratory Manual and Quick Reference Guides (if applicable); maintain and update these documents as applicable throughout the lifecycle of the project  

  • Work with cross-functional CTI laboratory departments to design project-specific tools and supplies such as sample requisition forms, sample labels, and lab kits 

  • Serve as liaison between logistics and data management to resolve issues with samples  

  • Implement project activities according to scope of contracted work 

  • Coordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the client  

  • Evaluate and manage project budget against project milestones and scope; work with laboratory leadership to take corrective measures where necessary to keep project in line with budget 

  • Assess scope of work against client contractual agreements and works with laboratory leadership to facilitate change of scope orders when appropriate 

  • Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes 

  • Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects 

  • Participate and contribute to site training meetings, such as Investigator meetings or site initiation visits 

  • Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.) 

  • Suggest and participate in process improvement activities and initiatives

Requirements

  • Bachelor’s degree or equivalent, preferably in allied health fields such as nursing, pharmacy, medical technology, or health science, preferably with central laboratory management experience 

  • Combined 4 to 6 years central lab and/or clinical research experience or possesses transferrable skills and experience in project management in a clinical setting or relatable industry

Categories

Posted: 2021-10-06 Expires: 2021-11-20

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Laboratory Project Manager

CTI Clinical Trial Services, Inc.
Cincinnati, Ohio

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