Director, Clinical Project Management (level dependent on experience)

CTI Clinical Trial and Consulting Services is a global, privately held clinical contract research organization focused on advancing treatments for critically ill patient populations. The Director of Clinical Project Management provides leadership in managing multiple global clinical research trials, ensuring successful execution while meeting sponsor requirements and fostering cross-functional collaboration.

Responsibilities:

• Plan, implement, facilitate and evaluate the full execution of 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 trial activities and deliverables
• Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
• Ensure that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) coordinate the organization and implementation of a clinical trial and manages the activities between all 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; escalate identified trial, CPM or CTI issues to executive management as needed; actively participate in resolution activities
• Oversee preparation of all study 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. Take corrective action where necessary
• Assess resource needs within team, with other CPM directors, Executive Director and other functional area managers to establish appropriate project team; monitor ongoing resource needs for project
• 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 CPM, who evaluates and manages regional project budget against project milestones; ensure that the CPM takes corrective measures where necessary to keep project in line with budget expectations
• Ensure that the CPM 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 Business Operations to ensure completion of needed contract amendments
• Synthesize and analyze new information against past 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 CPM 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 CPMs while encouraging independence and refinement of the CPM’s skills; provide regular performance evaluation and feedback to direct reports
• Review and assess internal and external quality assurance reports for assigned projects and ensure corrective action as necessary by the project management team
• Provide leadership in process improvement activities and initiatives; participate in the development and enhancement of integral aspects of the CPM operations
• Provide leadership and share expertise with clinical operations staff; facilitate the development of reference and resource materials for CPMs and clinical operations; participate in staff training and development activities
• Coach and train others in the CPM practices; promote and actively participate in the professional development of all CPM and CPC staff
• Participate in business development opportunities and the enhancement of globalization processes

Requirements:

• Bachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
• At least 12 years of clinical research experience and/or experience in clinical project management demonstrating a clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas
• Experience in management of clinical trials
• Thorough and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects
• Graduate degree