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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Location/Division Specific Information
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Discover Impactful Work:
As a Senior Director, Centralized Monitoring, you’ll provide operational and strategic leadership within the department for development and delivery of Risk Based Quality Management (RBQM) strategy and centralized monitoring (CM) objectives. The role is responsible for 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.
A day in the Life:
• Subject Matter Expert in Risk Based Quality Management (RBQM) methodologies, 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 and data strategy at the project and program level.
• Strategic lead overseeing team focused on driving risk assessment and defining mitigations and proper monitoring strategy for critical data and processes.
• Drives policy development and supports implementation of broader goals by working within clinical operations and across other functions and departments on the continuous development of business processes to support cross-functional teams.
• Drives resource utilization and quality within centralized monitoring.
• Supervises and coordinates centralized monitoring client risk and data strategy delivery, including mentoring managers and functional leads in day-to-day activities and responsibilities.
• 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.
• Contributes to future strategy and vision for CM, Clinical Operations 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.
Keys to Success:
Education
• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
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 cross functional adoption of Risk Based Quality Management
• Knowledge of industry regulatory and clincial standards such as ICH E6 & E8.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, 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 to strategic discussions while also remaining attuned to the details required for successful execution
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
