Senior Study Monitor
il y a 2 heures
**Senior Study Monitor - Clinaxel France**
**Clinaxel** is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.
We're actively seeking a **Senior Study Monitor based in France** to join our expanding **Field Clinical Trials** team.
**Primary Job Purpose**
Responsible for conducting and overseeing monitoring activities across clinical trial sites to ensure compliance with study protocols, VICH GL9 GCP guidelines, and regulatory requirements. This role involves verifying data accuracy, ensuring adherence to quality standards, and supporting the successful execution of clinical trials within established timelines and budgets. Key responsibilities include serving as the primary point of contact for assigned study sites, training site staff on protocols and compliance, and identifying and addressing site-level challenges. By maintaining high standards in monitoring practices, this role contributes to the integrity of research outcomes and supports advancements in animal health.
**Job Specific Duties and Responsibilities**
- Conduct site monitoring activities for all phases of clinical trials, including initiation, execution, and close-out, ensuring compliance with study protocols, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and quality of data collected at study sites and address discrepancies promptly.
- Serve as the primary point of contact for assigned study sites and investigators, facilitating effective communication and resolving site-level issues.
- Assist with the preparation and implementation of monitoring plans and study-related documentation.
- Provide training to site staff on study protocols, GCP guidelines, and compliance requirements.
- Compile detailed monitoring reports and communicate findings to the Clinical Trial Project Manager and other stakeholders.
- Identify and escalate risks affecting study timelines, quality, or compliance, and recommend corrective actions.
- Support the maintenance of study master files, ensuring organization and readiness for audits or submission.
- Collaborate with team members to ensure smooth execution of monitoring activities and adherence to project timelines.
- Promote adherence to organizational values and ethical research practices at study sites.
- Provide guidance, technical support and training to Monitors, Assistant Monitors, Monitor Associates and peers where applicable.
**Qualification, Training and Experience Requirements**
- Bachelor's degree in a relevant Life Sciences field.
- Minimum of four years' experience in Study Monitoring within Animal Health or Human Pharma sectors.
- Industry knowledge, including familiarity with FDA/CVM, EMA, VMD, VICH Guidelines, Clinical Field Trials, and Data quality requirements.
- Strong technical writing and oral presentation skills in English; proficiency in one or more other European languages is advantageous.
- Competence in Electronic Data Capture Systems.
- Demonstrated exceptional organizational and project management capabilities.
**Important Note to Applicants**
This is a hybrid position, with the potential for regular travel based on project requirements. Please note that Internet Explorer is not compatible with our recruitment platform (BambooHR Hire). We recommend using a modern browser such as Google Chrome, Microsoft Edge, or Safari.
Please send us your resume and a cover letter detailing your interest in the position.
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