Sr Director, Centralized Monitoring

at Thermo Fisher Scientific in Mount Prospect, Illinois, United States

Job Description

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.

The job:

As Senior 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.

Our organisation:

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 implement high-quality, cost-efficient clinical studies.

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

+ Advanced level of business English

What’s in it for you:

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!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.