CTI Clinical Trial and Consulting Services
Director, Clinical Project Management (level dependent on experience)
CTI Clinical Trial and Consulting Services, Covington, Kentucky, United States, 41011
Overview Director, Clinical Project Management (level dependent on experience). The Director provides leadership to direct reports and the clinical operations team in managing multiple and/or global clinical research trials across all functional areas. Responsible for guiding trial teams to successful execution, ensuring sponsor requirements are met with attention to budget, timelines and quality. Serves as the high-level operational contact at the project level and collaborates with Clinical Operations leadership to identify process improvements across clinical groups and studies, focusing on cross-functional collaboration and organizational development to foster effective trial execution.
The following information aims to provide potential candidates with a better understanding of the requirements for this role. What You'll Do
Plan, implement, facilitate and evaluate the full execution of assigned clinical trials; oversee management of multiple trials from planning to analysis for delivery to client May function in a global lead role on assigned trials and participate in day-to-day operations and/or oversight of trial activities and deliverables Ensure operational aspects comply with ICH guidelines, GCP, applicable regulatory guidelines and trial procedures Coordinate the organization and implementation of a clinical trial through CPMs and CPCs, managing activities across functional areas and the client Serve as primary senior interface on the project with executive management and sponsor; provide effective client management to prevent and mitigate issues; escalate as needed and participate in resolution activities Oversee study plans and timelines; monitor progress; suggest and implement alternatives to timelines, schedules, resources, budgets; take corrective action as necessary Assess and address resource needs within the team and across affiliated directors and managers to establish the project team Ensure use of appropriate project management tools to track progress and ensure timely entry of information throughout the project lifecycle Ensure training of assigned project teams; participate in staff training for projects as needed Oversee budgeted hours management by CPMs; evaluate and manage regional project budgets against milestones; implement corrective actions to align with budget expectations Assess scope of work against client contracts and assist with scope changes; review changes and ensure contract amendments as needed Analyze new information against past experience and sponsor expectations to develop strategies; keep CTI executive management and the client informed; initiate corrective action through CPMs Conduct or attend trial team and sponsor meetings; ensure agendas and minutes support effective trial communication and documentation Review weekly/monthly status reports to ensure quality and timely sponsor deliverables Report project progress, issues and scope considerations to executive management Provide input for new business development proposals; assist in project budgets and represent PM services during client presentations; participate in new business recruitment and marketing activities Provide supervision, guidance and mentoring to CPMs; conduct regular performance evaluations and feedback Review internal and external QA reports for assigned projects and ensure corrective actions as needed Lead process improvement initiatives; contribute to development and enhancement of CPM operations Provide leadership to clinical operations staff; develop reference and resource materials for CPMs; participate in staff training and development Coach and train others in CPM practices and support professional development of CPM and CPC staff Participate in business development opportunities and globalization processes as appropriate What You Bring
Bachelor’s degree in allied health fields (nursing, pharmacy, health science) or equivalent combination of education and relevant experience; clinical trial management experience preferred At least 12 years of clinical research experience and/or clinical project management with understanding of global trial management processes Experience in management of clinical trials Thorough understanding of at least one therapeutic area CTI contracts for Graduate degree 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. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. Why CTI?
Advance Your Career – Mentoring programs and leadership courses, tuition reimbursement, and a dedicated training department Join an Award-Winning and Valued Team – Global presence, work-life balance, health benefits, vacation, hybrid work options, paid parental leave, and CTI Cares program Make a Lasting Impact – Contribute to moving medicine forward for chronically and critically ill patients Important Note
We will never communicate via Microsoft Teams messaging or text; apply for jobs directly on our website or verified LinkedIn page We will never ask for bank information at any point during recruitment Equal Opportunity Employer CTI is an Equal Opportunity Employer/Veterans/Disabled. Seniority level
Director Employment type
Full-time Job function
Project Management and Information Technology Industries
Research Services
#J-18808-Ljbffr
The following information aims to provide potential candidates with a better understanding of the requirements for this role. What You'll Do
Plan, implement, facilitate and evaluate the full execution of assigned clinical trials; oversee management of multiple trials from planning to analysis for delivery to client May function in a global lead role on assigned trials and participate in day-to-day operations and/or oversight of trial activities and deliverables Ensure operational aspects comply with ICH guidelines, GCP, applicable regulatory guidelines and trial procedures Coordinate the organization and implementation of a clinical trial through CPMs and CPCs, managing activities across functional areas and the client Serve as primary senior interface on the project with executive management and sponsor; provide effective client management to prevent and mitigate issues; escalate as needed and participate in resolution activities Oversee study plans and timelines; monitor progress; suggest and implement alternatives to timelines, schedules, resources, budgets; take corrective action as necessary Assess and address resource needs within the team and across affiliated directors and managers to establish the project team Ensure use of appropriate project management tools to track progress and ensure timely entry of information throughout the project lifecycle Ensure training of assigned project teams; participate in staff training for projects as needed Oversee budgeted hours management by CPMs; evaluate and manage regional project budgets against milestones; implement corrective actions to align with budget expectations Assess scope of work against client contracts and assist with scope changes; review changes and ensure contract amendments as needed Analyze new information against past experience and sponsor expectations to develop strategies; keep CTI executive management and the client informed; initiate corrective action through CPMs Conduct or attend trial team and sponsor meetings; ensure agendas and minutes support effective trial communication and documentation Review weekly/monthly status reports to ensure quality and timely sponsor deliverables Report project progress, issues and scope considerations to executive management Provide input for new business development proposals; assist in project budgets and represent PM services during client presentations; participate in new business recruitment and marketing activities Provide supervision, guidance and mentoring to CPMs; conduct regular performance evaluations and feedback Review internal and external QA reports for assigned projects and ensure corrective actions as needed Lead process improvement initiatives; contribute to development and enhancement of CPM operations Provide leadership to clinical operations staff; develop reference and resource materials for CPMs; participate in staff training and development Coach and train others in CPM practices and support professional development of CPM and CPC staff Participate in business development opportunities and globalization processes as appropriate What You Bring
Bachelor’s degree in allied health fields (nursing, pharmacy, health science) or equivalent combination of education and relevant experience; clinical trial management experience preferred At least 12 years of clinical research experience and/or clinical project management with understanding of global trial management processes Experience in management of clinical trials Thorough understanding of at least one therapeutic area CTI contracts for Graduate degree 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. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. Why CTI?
Advance Your Career – Mentoring programs and leadership courses, tuition reimbursement, and a dedicated training department Join an Award-Winning and Valued Team – Global presence, work-life balance, health benefits, vacation, hybrid work options, paid parental leave, and CTI Cares program Make a Lasting Impact – Contribute to moving medicine forward for chronically and critically ill patients Important Note
We will never communicate via Microsoft Teams messaging or text; apply for jobs directly on our website or verified LinkedIn page We will never ask for bank information at any point during recruitment Equal Opportunity Employer CTI is an Equal Opportunity Employer/Veterans/Disabled. Seniority level
Director Employment type
Full-time Job function
Project Management and Information Technology Industries
Research Services
#J-18808-Ljbffr