Study Monitor Europe

2 settimane fa

Milano, Italia Clinglobal Group A tempo pieno

**Study Monitor - Europe**
Clinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry.
We're actively seeking a Europe-based Study Monitor to join our expanding Field Clinical Trials team This role provides the flexibility to work remotely, with occasional visits to Clinglobal group's offices.
**Primary Job Purpose**
Engage in Monitoring activities. Collaborate with the Clinical Trial Project Manager and Lead Monitor to ensure studies adhere to scientific design and timelines outlined in the study Protocol, Standard Operating Procedures (SOPs), Policies, regulatory guidelines, and quality standards (e.g., VICH GL9 GCP).
Serve as the primary contact for designated clinical study sites/Investigators, providing ongoing updates to the Clinical Trial Project Manager and/or Lead Study Monitor.
**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 point of contact between the Clinglobal group and study sites/Investigators.
- 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.
- Leading global study-level documentation and required tool and systems set-up.
- Author and review study Monitoring-related controlled documents, where applicable.
**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 potential for regular travel.
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