10+ years of clinical research experience or clinical project management in CTI.
Bachelor's degree in allied health fields (nursing, pharmacy, health science).
Experience in managing clinical trials effectively.
In-depth understanding of global trial management processes and clinical functional areas.
Expert knowledge in at least one therapeutic area relevant to CTI's clinical projects.
Responsibilities
Champion operational excellence through leadership and performance management.
Ensure timely delivery of team deliverables meeting all quality standards.
Proactively identify and address potential risks and capacity issues.
Maintain compliance with budget structures aligned to requirements and standards.
Drive workflow optimization by collaborating with Site Activation and cross-functional teams.
Standardize budget processes and templates for consistent execution.
Analyze operational data to provide actionable insights and improve performance.
Benefits
Opportunities for ongoing professional development and training programs.
Collaborative and cross-functional work environment.
Emphasis on operational excellence and continuous improvement.
Access to best practices and methodologies in clinical trials management.
Full Job Description
Job Summary: The Associate Director, Site Budgets provides leadership in the development, management and oversight of the trial site budgets team. The Associate Director also serves as the high-level operational contact with leadership and is responsible for coordinating the standardization and best practices for CTI site budget development processes. Focus is on organizational development to enhance cross-functional collaboration and to foster highly effective site budget execution for clinical trials.
What You'll Do:
Champion operational excellence, providing clear direction, prioritization, coaching, performance management and ongoing optimization to ensure consistent and high-quality on-time delivery.
Ensure team deliverables meet established timelines, quality standards and business requirements across studies and projects.
Proactively identify risks, capacity constraints, bottlenecks and upcoming milestones and implementing corrective actions as needed.
Ensuring budgets are appropriately structured, aligned with study, sponsor and regulatory requirements as well as organizational standards.
Identify opportunities to simplify, standardize, automate and optimize workflows in collaboration with Site Activation and cross-functional teams to improve cycle times, quality, scalability and stakeholder experience.
Establish and maintain standardized budget processes, tools, templates and operating procedures for site budget management, ensuring consistent execution across studies, regions and teams.
Monitor and analyze operational data and trends to identify opportunities for improved performance, anticipate challenges and provide actionable insights to senior leaders.
Lead resolution and escalation of complex or high-risk budget issues ensuring timely decision-making and appropriate escalation when study timelines, sponsor relationships, financial objectives or study delivery may be impacted.
Drive adoption of organizational change, new processes, systems and ways of working while ensuring team remains aligned with evolving business needs, industry practices and organizational objectives.
Site Activation team to share lessons learned and ensure continuous, streamlined improvement of the budget processes,
Plan, implement, facilitate, and evaluate the full execution of assigned clinical trials; may oversee management of multiple clinical trials from the planning phase to the analysis phase for delivery to 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
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
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 and scope 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 Development Operations to ensure completion of needed contract amendments
Provide supervision, guidance and mentoring to CPMs and provide regular performance evaluation and feedback to direct reports
Oversee and support the recruitment, resourcing, and management of site budget/payment specialists
Establish training programs to foster the development, effectiveness and advancement of site budget and payment services staff
Provide supervision, guidance and mentoring to site budget and payment specialists and provide regular performance evaluation and feedback to direct reports
Provide high-level review and oversight of site budget development for Requests for Proposals (RFP)
What You'll Bring:
At least 10 years of clinical research experience and/or experience in CTI clinical project management demonstrating a clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas.
Bachelor's Degree or equivalent in allied health fields such as nursing, pharmacy or health science
Experience in management of clinical trials
Thorough and current understanding of at least one therapeutic area for which CTI is contracted for clinical projects
