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

CTI Clinical Trial and Consulting Services•Covington, KY

27d

About The Position

The Associate Director provides leadership in managing multiple Phase I–IV clinical research trials across geographic and functional areas. The role ensures that direct reports and assigned clinical operations team members deliver projects on time, within budget, and at an acceptable level of quality. Working with assigned Clinical Project Managers and functional leadership, the Associate Director helps meet sponsor expectations and focuses on staff development, trial processes, improved trial execution, and organizational advancement. The position oversees clinical trials from planning through analysis and delivery to clients, and may serve as a global lead or participate in day-to-day operations and oversight. It provides senior-level sponsor and executive-management interface, supports project teams and Clinical Project Managers, monitors trial plans, timelines, budgets, resources, quality, and deliverables, and contributes to business development and process improvement.

Requirements

Bachelor’s degree in an allied health field such as nursing, pharmacy, or health science, or an equivalent combination of education and relevant work experience.
At least 10 years of clinical research experience and/or clinical project management experience, demonstrating a thorough understanding of global trial management processes and clinical trial functional areas.
Experience managing clinical trials.

Nice To Haves

Clinical trial management experience alongside a bachelor’s degree in an allied health field is preferred.
Thorough and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects.

Responsibilities

Plan, implement, facilitate, and evaluate execution of assigned clinical trials, overseeing multiple trials from planning through analysis and client delivery; may serve as a global lead or provide day-to-day operational oversight.
Ensure functional operations comply with ICH guidelines, Good Clinical Practices, applicable regulatory guidelines, and trial procedures.
Ensure assigned Clinical Project Managers and/or Clinical Project Coordinators coordinate trial organization and implementation and manage activities across functional areas and with the client.
Serve as the primary senior project interface with CTI executive management and the sponsor; manage client relationships, prevent and mitigate trial issues, escalate issues as needed, and participate in resolution activities.
Oversee preparation of study plans and timelines, monitor progress and compliance, propose solutions to timeline, schedule, resource, or budget problems, and take corrective action when necessary.
Assess resource needs with functional area managers and establish project teams with assigned Clinical Project Managers; monitor ongoing resource needs.
Ensure appropriate project management tools are used to track and report progress and metrics, and that team members enter project information promptly throughout the project.
Ensure project-team training and participate in project staff training as appropriate to expertise.
Oversee CPM management of budgeted hours and regional project budgets against milestones, ensuring corrective measures are taken when needed.
Ensure the CPM assesses scope of work against client contracts; assist with scope change orders, review scope notifications, and coordinate contract amendments with Business Operations.
Analyze new information, prior experience, trial milestone information, contracts, and sponsor expectations to develop problem-solving and project-advancement strategies.
Keep CTI executive management and the client informed, and ensure the CPM initiates corrective action.
Conduct or attend trial-team and sponsor meetings and ensure agendas and minutes support communication and documentation of oversight, discussions, and decisions.
Review weekly and/or monthly project status reports and other sponsor deliverables for quality before client submission.
Report project progress, issues, and scope-of-work considerations to executive management.
Contribute to new business development proposals, project budget preparation and review, client presentations, recruitment, and marketing; identify and communicate business opportunities to Business Development.
Supervise, guide, and mentor CPMs while encouraging independence and skill development; foster CPC professional development.
Review internal and external quality-assurance reports for assigned projects and ensure project-management teams take corrective action as needed.
Lead process-improvement activities and initiatives.
Provide leadership and expertise to clinical operations staff, facilitate development of CPM reference and resource materials, and participate in staff training and development.