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?
Utilize your relevant clinical research experience (minimum of 5 years), coupled with your B Sc degree in Life Sciences or related field.
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
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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