Associate Director, Clinical Project Management - up to $25K sign-on bonus!

CTI Clinical Trial and Consulting Services; Covington (KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

Hybrid work opportunities

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services is seeking an Associate Director to lead multi-Phase clinical trials across global functions. The role ensures on-time, on-budget delivery with quality, partnering with CPMs and functional leaders to advance trial execution and staff development.

The position emphasizes leadership, process improvement, and strategic trial oversight; CTI offers hybrid work options in the US and supports career growth within a global CRO framework.

Qualifications

• 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 10 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 preferred

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 as a global lead; may function in day to day operations and/or oversight of trial activities and deliverables
• Ensure the operational aspects of the functional areas comply with ICH guidelines, GCP, applicable regulatory guidelines and trial procedures
• Coordinate CPMs and CPCs to organize and implement a clinical trial and manage activities between all functional areas and the client
• Serve as primary senior interface on the project with executive management at CTI and the sponsor; manage client relationships
• Oversee preparation of all study plans and project timelines and monitor against progress; adjust plans; take corrective action
• Assess resource needs with functional area managers and establish appropriate project team with the CPM
• Ensure project management tools are used to track progress and ensure timely entry of project information
• Provide training to project teams; mentor CPMs and CPCs
• Oversee management of budgeted hours by CPMs against milestones; take corrective actions to stay on budget
• Ensure scope of work aligns with client contracts and assist with scope changes
• Synthesize new information to develop problem-solving strategies and advancement of the project
• Keep CTI execs and client informed; initiate corrective action
• Lead trial team and sponsor meetings with prepared agendas/minutes
• Review status reports for quality before client delivery
• Report progress and scope considerations to executives; support NBD proposals and client presentations
• Provide supervision and mentoring to CPMs and CPCs; foster staff development
• Review QA reports and drive corrective actions
• Lead process improvement initiatives and share expertise with clinical operations
• Develop reference materials and training for CPMs and CPCs; participate in staff development

Skills

Clinical trial leadership

Global trial management

Client management

Staff development

Education

Bachelor’s degree in allied health fields

10+ years clinical research experience

Equivalent combination of education and experience

Job description

Job Summary:

The Associate Director provides leadership role in facilitating the management of the multiple Phase I‑IV clinical research trials across all geographic and functional areas; Responsible for ensuring that direct reports and assigned clinical operation's team members deliver their projects on time, on budget and with an acceptable level of quality. Work with assigned Clinical Project Manager (CPM) and functional leadership to ensure sponsor expectations are met. Focus is on development of staff, trial processes and enhancement trial execution and organizational advancement.

What You'll Do

• 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 as a global lead; may function 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; escalated identified trial, staff 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 with functional area managers and establish appropriate project team in conjunction with assigned CPM; 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 projects, dependent upon expertise
• Oversee the management of budgeted hours by the CPMs, who evaluates and manages regional project budget against project milestones; ensure that the CPMs take corrective measures where necessary to keep projects 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 prior to forwarding to client and assure 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; foster professional development of CPC staff
• 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
• 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
  

What You Bring

• 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 10 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 preferred
  

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most
  

Equal Opportunity Employer/Veterans/Disabled