Medical Monitor

The essential role of the Medical Monitor is to contribute and provide methodological expertise on study design as well as medical and scientific input based on his/her medical knowledge when required. Endorse IMP (Investigational medical product) project in front of upper management and contributes providing adequate medical and scientific relationships with investigators, coordinate scientific committees and ensure clinical integrity of the trial subject

Tasks and Responsabilities

• Provide medical expertise to the study tam during key activities.
• Defines, gives support and endorse the rationale, objective and design of the study. 
• Responsible for the Clinical Safety activities including :review/ approve serious adverse events reports. Provide aggregate reports, DSURs; Annual Reports.
• Address safety issues across the study.
• Participate in the Safety Monitoring Committee for a specific Clinical trial when required
• If applicable, coordinate, review and approve the key documents such as protocol and clinical study report.
• Play a key role in the interaction with regulatory authorities.
• Coordinates the communication plans for the study results
• Identify opportunities to create a project publication plan when required

Reporting to: Head of Clinical Development

Ferrer guarantees equal treatment and opportunities, avoiding any type of prejudice or stereotyping, throughout the entire recruitment and integration process. Only objective criteria such as professional and academic ability and work experience will be assessed.