- Mitigate risks and manage triggers
- Identify potential site performance and patient safety issues
- Address early subject data issues
- Work with existing systems and data
- Provide medical review of subject level data for faster ID of potential trends and issues
- Enhance site services and CRA efficiency
- Complete customer service for accountability, transparency and oversight
- 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
- 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
- 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
Centralized Monitoring Lead, South Africa Homebased - Centurion, South Africa - IQVIA
Description
Centralized Monitoring Lead
Pharma companies may not have the experience and technology to implement risk-based monitoring solutions effectively. Do you want to be part of the solution by joining IQVIA Centralized Monitoring, where we accelerate the benefits of risk based monitoring (RBM), by providing a highly adaptive approach to best meet the sponsor's unique clinical operations requirements?
The Centralized Monitoring department has been operational since 2012 and has more than 600 staff globally. They have supported more than sites, 270 sponsors and 170 studies. A total of more than patients have been monitored
The IQVIA Centralized Monitoring team provide the following services to sponsors:
Key Activities:
What will enable you to be successful as a CML?
Required Knowledge, Skills and Abilities
Minimum Required Education and Experience
Bachelor's degree in life sciences or related field and min 5 years with relevant clinical research experience; or equivalent combination of education, training and experience
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at