Medical Evidence Generation Associate – Gulf

Key Responsibilities

• Assigned Studies oversight of deliverables at country level
• Ensure compliance of clinical research process with ICH-GCP practices, study protocol, AZ Global and Local Clinical SOPs, and regulatory authorities
• Perform site monitoring
• Ensure timely submissions to Ethics Committee/Regulatory Authority
• Prepare and conduct Investigator Meetings
• Create and implement alternative action plans for patient recruitment
• Lead activities related to setting up studies
• Coordinate site selection process
• Ensure timely readiness of Informed Consent Forms
• Plan and coordinate local drug activities
• Oversee monitoring activities from site activation through study closure
• Complete monitoring visit reports
• Organize regular Local Study Team meetings
• Contribute to patient recruitment strategy
• Manage risks and facilitate resolution of complex study problems
• Ensure accurate study-related payments
• Participate in training new team members
• Ensure completeness of essential documents for eTMF
• Plan and lead activities for audits and regulatory inspections
• Provide input to process development and improvement
• Collaborate with cross-functional teams

Requirements

Education

Bachelor's degree in Medical, Pharmacy or Health related field

Experience

Minimum 2 years of experience working in evidence generation or related fields

Required Skills

• Knowledge of ICH-GCP and local regulations
• Team leadership
• Cross-functional team motivation
• Organizational skills
• Verbal and written communication
• Prioritization and multitasking
• Attention to detail
• English proficiency
• Negotiation skills
• IT systems adaptation
• Travel ability