Senior Central Monitor

Position Summary

The Senior Central Monitor is responsible for delivering high-quality risk-based monitoring analytics to support clinical trial oversight. This role utilizes patient-level, site-level, country-level, and project-level data to identify potential risks impacting patient safety, protocol compliance, and data integrity.

The Senior Central Monitor performs centralized monitoring activities using advanced analytical tools and risk-based methodologies, enabling proactive identification, assessment, communication, and management of clinical trial risks. Working closely with cross-functional stakeholders, the role supports the implementation of monitoring strategies, oversight of quality metrics, and continuous improvement of clinical trial monitoring processes.

Key Responsibilities

- Plan and execute centralized monitoring activities in accordance with applicable SOPs, ICH-GCP guidelines, study requirements, and risk-based monitoring principles.
- Provide input to the Integrated Quality Risk Management Plan (IQRMP) and support risk assessment activities throughout the study lifecycle.
- Collaborate with key stakeholders to support the setup, validation, activation, and maintenance of central monitoring platforms and analytics tools.
- Conduct ongoing and periodic centralized review of: Patient-level clinical data
- Site performance metrics
- Country-level indicators
- Project quality metrics
- Key Risk Indicators (KRIs)
- Quality Tolerance Limits (QTLs)

- Analyze trends, identify signals, and detect potential issues related to patient safety, protocol compliance, data quality, and study conduct.
- Generate, evaluate, and escalate risk signals and propose appropriate corrective and preventive actions.
- Track identified risks, action items, and issue resolution activities to ensure timely closure.
- Communicate significant findings, trends, protocol deviations, non-compliance concerns, and other critical issues to relevant stakeholders.
- Support study teams in optimizing monitoring strategies through data-driven insights and risk trend analysis.
- Maintain accurate and complete documentation of centralized monitoring activities, findings, communications, and decisions.
- Facilitate and participate in Central Monitoring Outcome Review Meetings and risk review discussions.
- Partner with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Quality Assurance, and Study Management teams to drive study oversight and quality improvements.
- Mentor junior Central Monitors and provide guidance on risk identification, signal management, and centralized monitoring best practices.
- Contribute to continuous process improvement initiatives, departmental standards, and development of monitoring methodologies.

Minimum Qualifications

Education

- Bachelor's degree in Clinical Research, Life Sciences, Mathematics, Statistics, Pharmacy, Nursing, Public Health, or a related scientific discipline.
- Advanced degree preferred.

Experience

- Minimum 3 years of experience in clinical research, clinical trial operations, monitoring, data management, or related field.
- Minimum 2 years of experience performing centralized monitoring, risk-based monitoring, clinical analytics, or equivalent experience.
- Experience working in Phase I-IV clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare organization.
- Experience with risk-based monitoring methodology and centralized monitoring systems preferred.

Knowledge, Skills & Abilities

- Strong understanding of ICH-GCP, applicable regulatory requirements, and clinical trial processes.
- Solid knowledge of Risk-Based Quality Management (RBQM) and centralized monitoring principles.
- Advanced analytical and problem-solving skills with the ability to identify risk patterns, trends, and anomalies.
- Ability to interpret clinical, operational, and quality data from multiple sources.
- Proficiency in clinical technology platforms, dashboards, reporting tools, and data visualization applications.
- Excellent communication and stakeholder management skills.
- Ability to effectively manage multiple priorities and communication streams simultaneously.
- Demonstrated leadership and collaboration in cross-functional teams.
- Strong organizational skills with exceptional attention to detail.
- Ability to work independently while contributing effectively within a team environment.
- Proven capability to lead discussions related to study risks, quality concerns, and mitigation strategies.
- Fluent English communication skills, both written and verbal.

Preferred Qualifications

- Experience with RBQM frameworks and centralized monitoring technologies.
- Knowledge of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and quality oversight methodologies.
- Experience using clinical data visualization and analytics tools.
- Therapeutic area experience in Oncology, Rare Disease, Immunology, or Global Clinical Development programs is advantageous.
- Previous experience mentoring junior staff or providing functional leadership.

Core Competencies

- Risk Assessment & Signal Detection
- Clinical Data Analytics
- Quality Management
- Centralized Monitoring
- Study Oversight
- Stakeholder Management
- Regulatory Compliance
- Critical Thinking
- Problem Solving
- Communication & Influencing
- Leadership & Mentoring
- Continuous Improvement

This role plays a critical part in ensuring patient safety, data integrity, and study quality through proactive, data-driven risk identification and centralized oversight across global clinical trials.

We are committed to a transparent recruitment process. Where a salary range is not included in this job advertisement, shortlisted candidates will receive the applicable salary range before their first interview, in accordance with applicable local legislation

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 one 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 talking to you about working at Novotech.

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.