Director Project Mgmt Lab Services

Director Project Mgmt Lab Services

Join to apply for the Director Project Mgmt Lab Services role at CTI Clinical Trial and Consulting Services

Join to apply for the Director Project Mgmt Lab Services role at CTI Clinical Trial and Consulting Services

• Collaborate with functional areas across the lab business to develop systems, processes, templates, tools and SOPs, that will underpin the operationalization of lab services
• Plan, implement, facilitate, and evaluate the full execution of laboratory services assigned clinical trials; oversee management of multiple clinical trials from the planning phase to the analysis phase for delivery to client
• May function in global lead role on assigned trials and participate in day-to-day operations and/or oversight of laboratory activities and deliverables
• Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and applicable regulatory guidelines and trial procedures
• Ensure that assigned Laboratory Project Managers (LPM), Associate Laboratory Project Managers (APM) and Laboratory Project Coordinators (LPC) coordinate the organization and implementation of laboratory services for a clinical trial and manage the activities between all laboratory functional areas and the client
• Serve as primary senior interface on the project with executive management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues; elevate identified trial, PM or CTI issues to management as needed; actively participate in resolution activities
• Oversee preparation of all study laboratory plans and project timelines and monitor against project progress; ensure project activity compliance with plan(s); suggest and implement alternative solutions to problems with study timelines, schedules, resources, budgets, etc.
• Assess resource needs within team, to establish appropriate project team; monitor ongoing resource needs for all projects
• Ensure that appropriate project management tools are used to track and report project progress and metrics; ensure timely entry of project information by all team members throughout the life of the project
• Ensure training of assigned project teams; participate in staff training for his/her projects or other projects, dependent upon expertise
• Oversee the management of budgeted hours by the PM team; evaluate and manage regional project budget against project milestones; ensure that the PM takes corrective measures where necessary to keep project in line with budget expectations
• Ensure that the PM assesses scope of work against client contractual agreements and assist in changes of scope orders; provide review of changes in scope notifications and work with laboratory business operations to ensure completion of needed contract amendments
• Synthesize and analyze new information against experience, project information related to trial milestones in contracts and the sponsor expectations to develop strategies to facilitate effective problem solving and advancement of the project; keep CTI executive management and the client informed; ensure that the PM initiates corrective action
• Conduct or attend trial team and sponsor meetings; ensure that agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions, and decisions
• Review weekly and/or monthly project status reports as needed prior to forwarding to client to ensure the quality of those reports, as well as all other sponsor deliverables
• Report project progress, issues, and scope of work considerations to executive management
• Provide input for new business development (NBD) proposals, assist in project budget preparation / review, and represent project management services during NBD client presentations; participate in new business recruitment and marketing activities; seek NBD opportunities when appropriate and communicate these opportunities to business development
• Provide supervision, guidance and mentoring to PMs while encouraging independence…