Director Centralized Clinical Monitoring

Posted 3 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
170K-200K Annually
Senior level
Biotech
The Role
The Director Centralized Clinical Monitoring oversees Risk-Based Quality Management and centralized monitoring strategies, ensuring high-quality clinical trials and leading multidisciplinary teams.
Summary Generated by Built In

About the Role

The Director Centralized Clinical Monitoring is a senior leadership role responsible for the strategic and operational oversight of Risk-Based Quality Management (RBQM) and centralized monitoring capabilities. This role leads the design, delivery, and continuous improvement of centralized monitoring strategies to ensure high-quality, inspection-ready clinical trials, leveraging data-driven insights across global clinical programs.

Responsibilities

  • Provide strategic and operational leadership for global RBQM and centralized monitoring frameworks.
  • Serve as a subject matter expert for RBQM methodologies, tools, and centralized monitoring practices.
  • Lead the development and execution of risk assessments, monitoring strategies, and mitigation plans for critical data and processes.
  • Ensure consistent, high-quality delivery of centralized monitoring outputs across studies and programs.
  • Partner with Clinical Operations, Data Management, Biostatistics, Quality, and Technology teams to drive integrated data surveillance.
  • Develop and implement policies, standards, and best practices for centralized clinical monitoring.
  • Oversee resource planning, budgeting, and performance management for centralized monitoring teams.
  • Mentor, develop, and lead senior managers and subject matter experts within the RBQM function.
  • Act as an executive-level advisor to internal stakeholders and clients on RBQM and monitoring strategy.
  • Line Management to 10+ direct reports.

Experience and Qualifications 

  • Advanced degree in life sciences, clinical research, pharmacy, or a related discipline.
  • 15+ years of experience in pharmaceutical, biotechnology, or CRO environments.
  • Minimum 7 years of senior management experience in centralized monitoring, RBQM, or clinical operations leadership.
  • Deep expertise in RBQM methodologies and ICH E6/E8 principles.
  • Support business development activities by contributing RBQM expertise to proposals and client engagement.
  • Proven experience leading global, multidisciplinary teams and complex clinical portfolios. 

Salary Band – Director Centralized Clinical Monitoring $170,000 to $200,000 USD – Salary offered will be based on candidate's experience level.

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.  

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO).


At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. 


At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.


With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

About the Team

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. 
At Novotech you will work alongside empowered teams with a shared commitment to success.

  • Strategic vs transactional mindset.
  • Ability to gain insights and make proactive decisions quickly.
  • Culture that fosters partnership and collaboration, where every voice is heard and valued.
  • Ongoing support from senior stakeholders and leadership team.
.

Skills Required

  • Advanced degree in life sciences, clinical research, pharmacy, or a related discipline
  • 15+ years of experience in pharmaceutical, biotechnology, or CRO environments
  • Minimum 7 years of senior management experience in centralized monitoring or clinical operations leadership
  • Deep expertise in RBQM methodologies and ICH E6/E8 principles
  • Proven experience leading global, multidisciplinary teams and complex clinical portfolios
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The Company
1,524 Employees

What We Do

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.

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