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Sr Director, Centralized Monitoring

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Thermo Fisher Scientific

1mo ago

  • Job
    Full-time
    Expert Level
  • Healthcare
    Business, Operations & Strategy
  • Waltham, +58
    Remote

AI generated summary

  • You should have significant experience in centralized monitoring, strong leadership skills, and a deep understanding of regulatory compliance and data analytics in a scientific context.
  • You will oversee centralized monitoring processes, ensure data integrity, lead teams, manage projects, and collaborate with cross-functional groups to optimize operational efficiency.

Requirements

  • 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

Responsibilities

  • 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

FAQs

What is the work schedule for the Sr Director, Centralized Monitoring position?

The work schedule is standard Monday through Friday.

What are the primary responsibilities of the Sr Director, Centralized Monitoring?

The primary responsibilities include providing operational and strategic leadership for the development and delivery of Risk Based Quality Management (RBQM) strategy, overseeing centralized monitoring objectives, managing a team to complete CM deliverables, and ensuring quality in data and project strategy.

What qualifications are required for this role?

The role requires knowledge of the broad drug development process, expertise in the cross-functional adoption of Risk Based Quality Management, knowledge of industry regulatory and clinical standards such as ICH E6 & E8, 15+ years of experience in Pharma or CRO organizations, and extensive management responsibility.

What does Thermo Fisher Scientific offer in terms of employee benefits?

Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.

What is the importance of the centralized monitoring function in clinical trials?

Centralized monitoring plays a crucial role in Risk Based Quality Management by allowing for effective oversight of data quality and risk assessment, ultimately helping to improve health outcomes through efficient and high-quality clinical studies.

Is prior management experience necessary for this position?

Yes, extensive prior management responsibility is required for the Sr Director, Centralized Monitoring role.

What is the company culture like at Thermo Fisher Scientific?

The company culture is described as innovative and forward-thinking, emphasizing integrity, intensity, involvement, and innovation.

Will the Sr Director, Centralized Monitoring be involved in training staff?

Yes, the role includes training, management, and mentorship responsibilities within the department.

What kind of collaborative work is expected in this position?

The Sr Director will engage in collaborative outreach to adjacent departments and functions, facilitating communication and strategy implementation across the organization.

What kind of impact does this position have on client and patient outcomes?

This position directly impacts client success and patient outcomes by driving quality assurance and strategic monitoring in clinical trials, which helps improve health outcomes for individuals and communities.

Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.