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CTI Clinical Trial and Consulting Services · 2 days ago

Director, Clinical Project Management (level dependent on experience)

Covington, KY

Full-time

Hybrid

Director/Executive

12+ years exp

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on advancing treatments for chronically and critically ill patient populations. The Director of Clinical Project Management provides leadership and guidance to manage multiple global clinical research trials, ensuring compliance with regulations and successful project execution while fostering cross-functional collaboration and organizational development.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

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

Qualification

Clinical Project ManagementClinical Research ExperienceGlobal Trial ManagementTherapeutic Area KnowledgeBudget ManagementClient ManagementProcess ImprovementLeadershipMentoring

Required

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