Centralized Monitoring Lead, South Africa Homebased

Found in: Talent ZA C2 - 2 weeks ago

Centurion, South Africa IQVIA Full time

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 17 000 sites, 270 sponsors and 170 studies. A total of more than 100 000 patients have been monitored

The IQVIA Centralized Monitoring team provide the following services to sponsors:

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

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

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

#LI-Remote

#LI-Desiree du Plessis

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

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