Centralized Monitoring Lead -Cape Town at IQVIA

Key Activities:

• Partner with Clinical Lead or Project Lead on study to ensure quality and on-time site deliverables
• Oversee project aligned CAS activities
• Oversee Centralized Monitors
• Proactively oversee country CRA / CTA study deliverables
• Act as main point of contact for Investigational Products (IP) and non-IP related issues
• Oversee system access management and support access related issues
• Oversee timely ISF virtual binder creation
• Annotate country / site file review checklists, follow up / provide oversight of action item resolution for site / country level checklists, perform cross checks as per TMF Quality Plan / RMP and oversee compliance of reviews
• Manage project resources (CRAs/CMs/CTAs/CASs)
• Perform trend analysis of clinical aspects of the trail
• Share trends and agree on action plans
• Review, triage and actions clinical study alerts
• Monitor Clinical Operation Plan compliance

What will enable you to be successful as a CML?

• Familiarizing yourself with the study protocol, study team, study systems, study specific requirements and deliverables.
• Proactively identifying risk through trending and analysis and taking actions to mitigate risk
• Applying strong time management, prioritization and communication skills
• Positive issue resolution

Required Knowledge, Skills And Abilities

• In depth knowledge of Clinical Research functions like Monitoring, Project Management and Regulatory.
• Strong knowledge of the components of the protocol
• Strong communication and interpersonal skills, including good command of English language
• Excellent problem-solving skills
• Good teamwork skills
• Ability to work under limited direction
• Basic software and computer skills, including MS Office applications. Familiarity with related systems and software utilized in clinical operations
• Ability to establish and maintain effective working relationships with co-workers, managers and clients