Bachelor's degree in allied health fields (nursing, pharmacy, health science) or equivalent experience
10+ years of clinical research and/or project management experience
Proven understanding of global trial management processes
Experience managing clinical trials
Familiarity with at least one therapeutic area relevant to CTI's projects
Responsibilities
Plan and oversee execution of multiple clinical trials from start to finish
Ensure compliance with ICH guidelines, GCP, and regulatory standards
Act as primary interface with executive management and sponsors
Monitor project timelines and budgets, implementing corrective actions as needed
Assess resource needs and establish project teams with functional area managers
Utilize project management tools to track progress and metrics
Provide training and mentorship to project teams
Benefits
Opportunities for professional development and training
Engagement in process improvement initiatives
Involvement in new business development and marketing activities
Supportive leadership fostering independence and skill refinement
Access to a collaborative work environment with clinical operations staff
Full 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; 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 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
