Principal Central Monitor

About the Role

A contract research organization with a dermatology focus is hiring a Principal Central Monitor to act as a technical and strategic authority for centralized monitoring programs. This position is central to managing clinical trials ranging from Phase I to IV by spearheading the creation of creative tools, procedural manuals, and analytical structures for centralized statistical data evaluation. You will function as the main authority on centralized monitoring, steering department-wide efforts and guaranteeing that all tasks correspond with project risks, key data variables, and set procedures from the beginning of the project until the database is locked. You will contribute to the caliber of clinical research results through advanced risk management, automation of processes, and training of less experienced personnel, all while working within a remote-first, flexible setting located in the Philippines.

Requirements

• You must hold a bachelor’s degree in a discipline related to clinical research and have a minimum of 5 years of focused experience in central statistical monitoring.
• You are required to have 10 years of overall professional tenure spanning at least two operational disciplines, such as biometrics, data management, clinical monitoring, drug safety, or project management.
• You should have a comprehensive grasp of clinical trial database platforms like CTMS, IRT, and EDC, alongside statistical monitoring and Risk Based Quality Management.
• Proficiency in descriptive analysis and Microsoft Office is mandatory, along with the capacity to analyze clinical study protocols and pinpoint intricate data patterns.
• You must have legal authorization to work in the Philippines, possess professional fluency in English, and exhibit the ability to correspond clearly with both internal staff at all levels and outside clients.

Responsibilities

• You will design and execute monitoring strategies tailored to individual studies, including automated instruments for extracting and evaluating data to detect performance problems and systemic inaccuracies.
• You will serve as the monitoring department's representative in interdisciplinary meetings focused on risk assessment, offering advice on how to detect, rank, and address study-related hazards.
• Your work entails directing technical reviews, handling escalated problems, and establishing uniform benchmarks for risk-based monitoring activities.
• Furthermore, you will train and guide newer personnel, offering support for intricate project requirements and assisting management with the framing and documentation of risks.
• You are also expected to monitor documentation of prospective risks and work with peers across departments to maintain data accuracy, which could necessitate attending meetings beyond typical working hours.

Benefits & Perks

• This is a full-time, permanent role featuring a flexible work schedule and the ability to work remotely.
• Staff members are granted access to continuous professional growth and educational opportunities.