Associate Director, Clinical Project Management (level dependent on experience)

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; escalate 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 ...