.This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule: Standard (Mon-Fri)Environmental Conditions: OfficeAt 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.The job:As Executive Director, Centralized Monitoring, you'll provide operational and strategic leadership for the development and delivery of Risk Based Quality Management (RBQM) strategy and centralized monitoring objectives.You will be responsible for directing, leading, and managing your assigned team to successfully complete CM deliverables in support of clients and studies.Your role will involve training, management, and mentorship within the department, as well as collaborative outreach to adjacent departments and functions.What will you do?Serve as a Subject Matter Expert in Risk Based Quality Management (RBQM) methodologies, tools, processes, and central monitoring methods.Develop and manage client and partner relationships, mentoring and directing staff and management, including overseeing and ensuring quality of RBQM and data strategy at the project and program level.Drive risk assessment and define mitigations and proper monitoring strategy for critical data and processes.Drive policy development and support implementation of broader goals by working across departments.Supervise and coordinate centralized monitoring client risk and data strategy delivery.Ensure the CM teams are provided with the necessary support and resources.Manage staff and management, including interviewing, professional development, and performance management.Lead internal and cross-functional initiatives, including process and tool development.Contribute to future strategy and vision for CM and Clinical Operations.Who we are looking for:Knowledge of broad drug development process and expertise in cross-functional adoption of Risk Based Quality Management.Knowledge of industry regulatory and clinical standards such as ICH E6 & E8.15+ years of previous experience within Pharma or CRO organisations, providing the knowledge, skills, and abilities to perform the job.Extensive prior management responsibility
