Study Monitor

7 giorni fa

Milano, Italia Clinglobal Group A tempo pieno

**Study Monitor - Clinaxel Europe**

**Clinaxel** is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.

We're actively seeking a **Study Monitor**based in Southern Europe** to join our expanding **Field Clinical Trials** team. This role provides the flexibility to work remotely, with occasional visits to Clinaxel offices based in the North of France.

**Primary Job Purpose**

Responsible for conducting monitoring activities to ensure that clinical trials are executed in full compliance with the study protocol, VICH GL9 GCP guidelines, and all applicable regulatory requirements. This role plays a critical part in verifying data accuracy, overseeing site adherence to timelines and quality standards, and contributing to the overall success and integrity of clinical trials.

**Job Specific Duties and Responsibilities**
- Monitor study sites, including activities associated with study initiation, execution, close-out, and submission, and verify the data collected.
- Compile Monitor reports to report on the progress of the study and obtain corrective actions as necessary.
- Train sites on study protocols and GCP.
- Assist with site selection and evaluation.
- Serve as a point of contact for assigned study sites/investigators, facilitating communication and addressing site issues.
- Assist the Clinical Trial Project Manager with study activities, including but not limited to reviewing draft protocols, overseeing sites’ budgets and invoices, and maintenance of monitoring tools.
- Serve as point of contact for new clinical study sites/Investigators.
- Provide oversight of study master files (electronic and paper) and prepare the study files for archiving/submission.
- Ensure study sites/Investigators fulfil their responsibilities to meet the agreed timelines, quality, and cost.
- Proactively identify risks that might jeopardize projects, e.g., technical feasibility, sites’ suitability, timely execution, budget constraints, etc.
- Develop and maintain project management tools, including but not limited to Gantt charts, project budgets, forecasts, etc.
- Promote the organization’s capabilities and values internally and externally.
- Provide guidance, technical support and training to Assistant Monitors, Monitor Associates, and peers where applicable
- _Please note:_ this list of duties is not exhaustive and may be amended from time to time to reflect operational needs or organizational changes.

**Qualification, Training and Experience Requirements**
- Bachelor's degree in a relevant Life Sciences field.
- Minimum of three 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 remote 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.

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