Clinical Trial/CRO Medical Monitor - Safety Data Analyst I

The Clinical Trial/CRO Medical Monitor/Safety Data Analyst will process Adverse Event (AE) and Serious Adverse Event (SAE) cases, assisting in the conduct of pre- and post-marketing studies. They will also handle Medical Coding and Medical Monitoring activities, and oversee study conduct, safety case preparation, and reporting. The role involves interaction with Sponsors and direct communication with individuals involved in project activities.

Requirements

• Oversee the conduct of pre- and post-marketing studies regarding Safety of study subjects.
• Perform medical review of Protocols, Investigator’s Brochures, Case Report Forms, and Informed Consent forms.
• Develop Pharmacovigilance, Safety Management, and Medical Monitoring Plans.
• Prepare safety case reports using MedWatch and CIOMS-I forms.
• Maintain and reconcile safety and clinical databases.