Senior Project Manager, Laboratory Services

What You'll Do

• Plan, implement, evaluate, and complete execution of assigned laboratory clinical trials/projects; may function as a global lead, where applicable. Expected to manage more complex trials.
• 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 clinical trials/projects
• Provide oversight and coordination of the operational aspects of the functional areas on assigned clinical trials/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 clinical trials/projects including global clinical trials/projects from start-up through closeout; provide oversight of functionally assigned teams members on laboratory clinical trials/projects; manage multiple clinical trials/projects simultaneously
• Work closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projects
• Provide coordination of a laboratory clinical trial/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 clinical trial/project
• Participate in or provide oversight and guidance in the development of clinical trial/project required deliverables
• Serve as Global Project Manager and/or client contact at clinical trial/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 clinical trial/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 clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issues
• Ensure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/project
• In conjunction with the client and cross-functional CTI laboratory departments, create the Laboratory Specifications Plan based upon contracted services at the initiation of a new clinical trial/project, and maintain and update the document as needed throughout the lifecycle of the clinical trial/project
• Build clinical trial/project-specific laboratory database in lab information management system (LIMS) at initiation of a new clinical trial/project; maintain and update the database as needed throughout the lifecycle of the clinical trial/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 clinical trial/project
• Work with cross-functional CTI laboratory departments to design clinical trial/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 clinical trial/project budget against project milestones and scope; work with laboratory leadership to take corrective measures where necessary to keep clinical trial/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 clinical trial/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
• Develop and perform periodic r