Central Monitor-Philippines Remote – English – Philippines · Permanent · Professional

Indero; Philippines; Remote; PHP 850,000 - 1,250,000; Full time

Benefits offered by this job

Flexible work schedule

Permanent full-time position

Ongoing learning and development

Job summary

Indero is seeking a Central Monitor in the Philippines to conduct remote review of clinical data throughout studies, supporting a centralized monitoring plan. The role focuses on identifying data quality trends, managing risk, and documenting findings with senior team support from start to database lock.

Ideal candidates have a Bachelor’s in clinical research and at least 1 year in central monitoring with 6+ years in related areas, plus RBQM familiarity and strong MS Office proficiency.

Qualifications

• Bachelor’s degree in a field relevant to clinical research.
• Minimum 1 year in central statistical monitoring and 6 years in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
• Basic understanding of RBQM and its impact on data integrity.
• Knowledge of clinical trial database systems (EDC, IRT, CTMS).
• Strong MS Office skills and ability to learn interactive systems.
• Experience analyzing clinical data and identifying data trends.

Responsibilities

• Follow established procedures for reviewing clinical data using various tools.
• Identify data quality trends indicative of errors and track risks with senior support.
• Ensure results of reviews are documented per procedures.
• Support Central Monitoring with high quality, timely reviews.
• Provide input to senior team on risk characterization and reporting.
• Assist review setup, update databases, pull reports as directed.
• Share responsibility for data quality at study, country, and site levels.

Skills

English fluency

RBQM knowledge

Statistical monitoring

Data interpretation

MS Office

Education

Bachelor’s degree in a field relevant to clinical research

Tools

EDC systems

IRT

CTMS

Job description

## Central Monitor-PhilippinesRemote - English - Philippines · Permanent · Professional#### About The PositionCentralized monitoring is an integral part of a risk-based monitoring strategy, defined as the timely, remote review of accumulating subject and operational data to help distinguish between reliable and unreliable data, trends, outliers, and unusual variability using analytics and statistical methods.The central monitor is responsible for conducting a holistic and centralized statistical review of study data from study start through to study database lock according to the centralized monitoring plan, using analytical tools to identify emerging and existing risks to critical study data and process. The central monitor enables proactive identification, communication, escalation and management of risks at the study/country/site level. **RESPONSIBILITIES*** Follow established procedures for the review of clinical trial data (Operational and Subject data) using a variety of tools and systems in alignment with the centralized monitoring plan and with support from the senior team members.* Identify data quality trends indicative of systematic errors and potential performance issues at study/country/site and track the evidence of issues and potential risks with support from senior team members.* Ensure results of reviews are appropriately documented per procedures.* Support Central Monitoring teams with performance of assigned reviews with high quality, on-time results.* Provide input to senior team member as needed to support development of risk characterization and reporting.* Support review set-up as directed by assigned lead including updating department database, pulling reports, etc. as assigned.* Share the responsibility for data quality at the study, country and site levels.#### Requirements**Education*** Bachelor’s degree in a field relevant to clinical research.**Experience*** Minimum of 1 year of experience in central statistical monitoring with overall 6 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.* Basic understanding of statistical monitoring and Risk Based Quality Management (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, etc.).* Good computer skills, with knowledge of advanced MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems and tools.* Ideally a basic level of understanding of descriptive analysis e.g. means, medians, significance, confidence intervals.* Must have been involved in the analysis and review of clinical data, ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems with the ability to learn to identify trending of site/study data.* Must be able to work in non-traditional work environments.**Attributes*** Fluent in English (excellent oral and written).* Must be able to communicate clearly and effectively at all levels in an organization and with external customers.* Must be a fast learner and able to understand new concepts quickly.* Prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands.* Satisfactory understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.* Broad working knowledge of the roles, functions and process of conducting clinical trials.* Must be able to manage time effectively, working with multiple functions and requirements.* Must have been involved in the use of trial management or data management systems.* Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.#### 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.In this position, you will be eligible for the following perks:* Flexible work schedule* Permanent full-time position* Ongoing learning and development**Work location****Note that this opening is for a home-based position in Philippines. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.****About Indero**A Global Clinical Leader In**Dermatology and Rheumatology!**Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.*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 Philippines.*#### Apply for this position