Senior Director, Clinical Project Management

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Plan, implement, facilitate, and evaluate the comprehensive execution of designated clinical trials; manage multiple clinical trials from the planning stage to the analysis phase for client delivery;

• Ensure that the operational components of the functional areas adhere to the International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), relevant regulatory guidelines, and trial protocols.

• Confirm that assigned Clinical Project Managers (CPM) and/or Clinical Project Coordinators (CPC) organize and execute a clinical trial, managing activities across all functional areas and with the client.

• Act as the primary senior liaison on the project with executive management at CTI and the sponsor; deliver effective client management to avoid and address trial challenges; escalate identified trial, CPM, or CTI issues to executive management as necessary and actively engage in resolution efforts.

• Supervise the development of all study plans and project timelines, monitoring project progress; ensure compliance with project activity plans; propose and implement alternative solutions to issues related to study timelines, schedules, resources, budgets, etc.

• Take corrective measures as needed.

• Evaluate resource needs within the team, collaborating with other CPM directors, the Executive Director, and other functional area managers to establish an appropriate project team; monitor ongoing resource requirements for the project.

• Ensure the utilization of appropriate project management tools to track and report project progress and metrics; guarantee timely entry of project information by all team members throughout the project lifecycle.

• Ensure training for assigned project teams; participate in training sessions for his/her projects or other projects based on expertise.

• Oversee budgeted hours managed by the CPM, who assesses and manages the regional project budget against project milestones; ensure that the CPM implements corrective actions as necessary to align the project with budget expectations.

• Confirm that the CPM evaluates the scope of work against client contractual agreements and assists in changes to scope orders; review changes in scope notifications and collaborate with Business Operations to ensure the completion of necessary contract amendments.

• Synthesize and analyze new information in relation to past experiences, project data concerning trial milestones in contracts, and sponsor expectations to devise strategies that facilitate effective problem-solving and project advancement; keep CTI executive management and the client informed; ensure that the CPM initiates corrective actions.

• Conduct or participate in trial team and sponsor meetings; ensure that agendas and minutes are effectively prepared to enhance trial communication and document trial oversight, discussions, and decisions.

• Review weekly and/or monthly project status reports as necessary before forwarding to the client to guarantee the quality of these reports and all other sponsor deliverables.

• Communicate 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; engage in new business recruitment and marketing initiatives; seek NBD opportunities when appropriate and relay these opportunities to Business Development.

• Offer supervision, guidance, and mentoring to CPMs while fostering independence and the refinement of their skills; provide regular performance evaluations and feedback to direct reports.

• Review and evaluate internal and external quality assurance reports for assigned projects, ensuring corrective actions are implemented as necessary by the project management team.

• Lead process improvement activities and initiatives; participate in the development and enhancement of key elements of CPM operations.

• Provide leadership and share expertise with clinical operations staff; facilitate the creation of reference and resource materials for CPMs and clinical operations; engage in staff training and developmental activities.

• Coach and train others in CPM practices; promote and actively participate in the professional development of all CPM and CPC staff.

• Engage 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 experience in clinical trial management, or an equivalent combination of education and relevant work experience.

• A minimum of 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 managing clinical trials.

• In-depth and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects is preferred.

• A graduate degree is preferred.

🏝️ Benefits

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the necessary support for growth.

• We also prioritize ongoing education and training through tuition reimbursement and a dedicated training department.

• Join an Award-Winning and Valued Team – We have a unique, award-winning culture that resonates with our employees across 60 countries.

• We promote work-life balance and the importance of family time by offering generous health benefits and vacation packages, hybrid work-from-home opportunities, and paid parental leave.

• We encourage care for the world around us through our unique CTI Cares program.

• Make a Lasting Impact – We focus on advancing medicine by working on treatments for chronically and critically ill patients who rely on us to bring life-changing therapies to market.