The role focuses on supporting CMS leads to achieve project objectives while optimizing speed, quality, and cost of delivery
Job Summary
The role focuses on supporting CMS leads to achieve project objectives while optimizing speed, quality, and cost of delivery.
Candidates will be responsible for reviewing site visit reports, ensuring data integrity, and escalating issues in compliance with ICH/GCP guidelines.
This position requires managing operational insights, performing trend analysis, and developing analytics strategies to address clinical risks identified during trials.
Matching Summary
The role focuses on supporting CMS leads to achieve project objectives while optimizing speed, quality, and cost of delivery.
Skills & Requirements
Must-have
ICH GCP regulatory compliance knowledge
Centralized monitoring plan development
Site visit report review expertise
Clinical data quality assurance
Risk assessment and mitigation planning
Nice-to-have
Mentoring junior centralized monitoring staff
Cross-functional team collaboration skills
Advanced analytical tool proficiency
Strong verbal communication abilities
Experience with therapeutic area specifics
Key Requirements
Bachelor's degree in Clinical, Life Sciences, or related field
Minimum 4 years of relevant work experience
At least 2 years in centralized monitor role preferred
Knowledge of clinical trial conduct and regulations