Our client, a growing biotech client with a robust pipeline of assets targeting hard to treat cancers, is seeking an EU medical monitor to join their team.
Your responsibilities will include:
Oversight of approximately 50 sites across Europe, ensuring proper conduct and compliance with the study protocol. Ensure adherence to EMA regulations, GCP, and other relevant guidelines. Monitoring of data collection, entry, and validation processes to ensure accuracy and completeness. Identification and mitigation of risks associated with clinical trials. Reviewing protocol deviations. Provision of training and support to clinical trial staff on regulatory requirements and study protocols. Serving as a primary point of contact for clinical trial sites, investigators, and regulatory authorities. Ideally you will have:
A medical degree, preferably with specialization in Oncology. At least five years experience in a medical monitoring capacity. Prior experience in working on a phase III study. Excellent communication skills. Proficiency in Spanish or Italian language would be advantageous.
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Oversight of approximately 50 sites across Europe, ensuring proper conduct and compliance with the study protocol. Ensure adherence to EMA regulations, GCP, and other relevant guidelines. Monitoring of data collection, entry, and validation processes to ensure accuracy and completeness. Identification and mitigation of risks associated with clinical trials. Reviewing protocol deviations. Provision of training and support to clinical trial staff on regulatory requirements and study protocols. Serving as a primary point of contact for clinical trial sites, investigators, and regulatory authorities. Ideally you will have:
A medical degree, preferably with specialization in Oncology. At least five years experience in a medical monitoring capacity. Prior experience in working on a phase III study. Excellent communication skills. Proficiency in Spanish or Italian language would be advantageous.
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