Central Monitoring Manager-Romania

Description

The Central Monitoring Manager is responsible for the strategic and operational oversight of centralized monitoring activities across studies, from study start-up through database lock. This includes leading the development and implementation of study-specific centralized monitoring plans, supervising central monitor teams, and driving proactive risk identification and mitigation efforts. The role ensures centralized data reviews are completed with high quality and in alignment with timelines and contributes to cross-functional risk management and continuous process improvement.

More specifically, the Central Monitoring Manager must:

• Oversee the development and execution of centralized monitoring plans across studies, ensuring consistency with RBQM strategy.
• Lead and manage a team of Central Monitors, providing guidance, oversight, and performance management.
• Ensure centralized monitoring reviews are completed to quality standards, on time, and within budget.
• Review and interpret data quality trends and operational signals to identify emerging risks at the study, country, and site levels.
• Contribute to risk assessments, periodic data reviews, and risk mitigation strategies in collaboration with cross-functional teams.
• Represent the Central Monitoring function in cross-functional meetings, audits, and client-facing discussions.
• Provide input into process improvement initiatives, tool development, and refinement of centralized monitoring methodologies.
• Ensure documentation of reviews and decision-making aligns with SOPs and regulatory expectations.
• Support training and development of Central Monitoring staff, ensuring alignment with protocol and project strategy.
• Coordinate resource planning and allocation for centralized monitoring activities across assigned studies.
• Maintain oversight of centralized monitoring data systems, reporting outputs, and departmental databases.

Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements

Experience:

• Bachelor’s degree in a field relevant to clinical research.
• Minimum of 5 years of experience in centralized monitoring, with 12+ years in clinical research across functions such as clinical monitoring, data management, biometrics, or project management.
• Experience in line management a plus.
• Strong understanding of statistical monitoring principles, RBQM frameworks, and regulatory expectations related to clinical trial oversight.
• Hands-on experience with clinical trial database systems (e.g., EDC, IRT, CTMS) and data analytics tools.
• Demonstrated ability to analyze clinical data, identify meaningful trends, and drive data-driven decisions.
• Experience supervising and mentoring staff, with proven leadership in cross-functional environments.
• Ability to manage multiple projects and priorities in a dynamic environment.

Attributes:

• Fluent in English (excellent oral and written communication skills).
• Strong analytical and problem-solving abilities.
• Effective communicator with the ability to engage internal teams and external clients.
• Highly organized, with the ability to manage workload, timelines, and shifting priorities.
• Knowledge of GCP, ICH guidelines, and applicable global regulations (e.g., FDA, Health Canada).
• Collaborative mindset with a commitment to continuous improvement and quality.
• Skilled in the use of Microsoft Office (Word, Excel, PowerPoint) and other business applications

Our company

OUR COMPANY 

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

As a Central Monitoring Manager, you will be eligible for the following perks: 

• Flexible work schedule
• Permanent full-time position
• Home-based position
• Ongoing learning and development

About Indero

Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Indero only accepts applicants who can legally work in Romania.