Provides operational and strategic leadership within the department for development and delivery of centralized monitoring (CM) objectives. Provides direction, leadership and management to assigned team and to drive the successful completion of CM deliverables in support of assigned clients and studies. This includes training, management and mentorship within the department as well as collaborative outreach to adjacent departments and functions to contribute to the successful delivery of clean data from evaluable patients within project parameters of time, quality, and cost. Drives resource utilization and quality within centralized monitoring. Drives policy development and supports implementation of broader goals by working across other functions and departments on the continuous development of business processes to support cross-functional teams.
Essential Functions and Other Job Information:
Subject Matter Expert in Centralized Statistical Monitoring, tools, processes and central monitoring methods
Develops and manages client and partner relationships, mentors and directs staff and management on same, including overseeing and ensuring quality of RBQM, centralized monitoring reviews and data strategy at the project and program level. ·
Strategic lead overseeing team focused on driving signals and insights for quality data surveillance
Ensures the CM teams are provided with the necessary support and resources to successfully deliver CM deliverables.
Manages staff and management, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
Lead internal and cross-functional initiatives, including process and tool development.
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Contributes to future strategy and vision for CM, Integrated Data services and cross-functional evolution.
Serves as key integration point with other functional departments and contributes to overall strategic planning initiatives, development and implementation of operational initiatives.
Attends and captures critical operational items from strategy and team discussions; formulates ideas into slide presentations and briefings.
Provides counsel at the executive level on operational issues. Establishes policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices. Develops and is responsible for budgets, schedules, and performance standards
Objectives established under specific senior management direction.
Interacts with senior management, and others concerning matters of significance to the company. Conducts business and technical briefings for senior and top management and for external management and / or representatives
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years). 7+ years of management responsibility
Advanced leadership skills
Advanced knowledge of broad drug development process and expertise in centralized statistical monitoring.
Knowledge of industry regulatory and clinical standards such as ICH E6 & E8.
Knowledge, Skills and Abilities:
Expert ability to cultivate collaborative internal/external networks/relationships
Demonstrates robust judgment, problem solving and decision making; Ability to apply critical and analytical thinking and business acumen to develop effective solutions
An expert with leading large-scale, cross functional initiatives, large cross-functional teams or projects and influencing senior level management and key stakeholders
Exceptional leadership, change management, planning, organizing and resourcing skills
Strong at driving alignment, managing time, and managing priorities
A great communicator and negotiator able to develop shared perspectives
Ability to handle complex situations and multiple responsibilities simultaneously mixing long term projects with the urgency of immediate demands on the operations
Ability to collaborate with and achieve actionable results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization
Demonstrated analytical skills with the ability to judge situations accurately and quickly, grasping complexities, identifying key issues and applying sound judgment
Ability to quickly and effectively build credibility and strong relationships at all levels
A high tolerance for ambiguity and the ability to navigate complexity
A “big-picture” thinker with the ability to stand above the day-to-day deliverables when required and contribute meaningfully
Management Role:
Director role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of director skills and responsibilities as demonstrated by consistent, multi-year successful performance. Directs through subordinate management. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.
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