Senior Central Monitoring Lead: RBQM & Analytics

Indero (formerly Innovaderm); Philippines; Teletrabalho; PHP 995 000 - 1 526 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible work schedule

Permanent full-time position

Ongoing learning and development

Resumo da oferta

Indero (formerly Innovaderm) seeks a Principal Central Monitor to lead centralized monitoring across multiple studies, developing tools and guidelines to support risk-based reviews and data integrity from study start to database lock.

The role demands 5+ years in central statistical monitoring, 10+ years across related areas such as clinical monitoring, data management, and biometrics; strong RBQM and data systems knowledge; fluent English and excellent communication.

Qualificações

• Bachelor’s degree in a field relevant to clinical research.
• Minimum of 5 years of experience in central statistical monitoring with an overall 10 years in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
• Excellent understanding of statistical monitoring and RBQM and their impact on data integrity.
• Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
• Knowledge of clinical trial database systems (EDC, IRT, CTMS).
• Advanced level of using MS Office and ability to learn interactive systems.
• Ability to perform descriptive analysis (means, medians, significance, confidence intervals).
• Must be able to work in non-traditional work environments.
• Fluent in English (excellent oral and written).
• Clear and effective communication at all levels.

Responsabilidades

• Lead development of new tools, instruction guidelines and analyses within centralized monitoring.
• Lead setup of study-specific tools, analyses, and monitoring plans aligned with study risks.
• Act as strategic and technical lead for centralized monitoring across multiple studies and initiatives.
• Assist in creating tools and processes for automating risk-based monitoring tasks.
• Mentor and train new team members and junior staff.
• Identify data quality trends and risks with evidence tracking.
• Represent centralized monitoring in cross-functional risk assessment meetings.
• Provide input to leadership on risk characterization and reporting.

Conhecimentos

Central statistical monitoring

RBQM knowledge

Data management systems

Statistical analysis

MS Office advanced

English fluency

Communication

Time management

Project management

Formação académica

Bachelor's degree in clinical research

Ferramentas

EDC

IRT

CTMS

Descrição da oferta de emprego

Indero (formerly Innovaderm) seeks a Principal Central Monitor to lead centralized monitoring across multiple studies, developing tools and guidelines to support risk-based reviews and data integrity from study start to database lock.

The role demands 5+ years in central statistical monitoring, 10+ years across related areas such as clinical monitoring, data management, and biometrics; strong RBQM and data systems knowledge; fluent English and excellent communication.