Faculty: Charles Paul | Code: PM356114
Clinical trial project management involves a range of activities aimed at ensuring that a clinical trial is conducted efficiently, ethically, and in compliance with regulatory requirements. Successful clinical trial project management requires careful planning, coordination, and communication among stakeholders, including sponsors, investigators, participants, and regulators. In this webinar, I will discuss some best practices for clinical trial project management.
Those best practices include:
WHY YOU SHOULD ATTEND:
Clinical trial project management is a complex and dynamic process that requires careful planning, coordination, and communication among stakeholders. Defining clear project objectives and scope, developing a comprehensive project plan, establishing effective communication channels, implementing risk management strategies, ensuring compliance with regulatory requirements, and ensuring data integrity and quality are all essential best practices for clinical trial project management.
Successful clinical trial project management requires a deep understanding of the scientific, regulatory, and operational aspects of the trial, as well as the ability to manage resources, timelines, and risks effectively.
This webinar will establish that fundamental link between the process of conducting clinical trials and the basic tenants of project management.
AREAS COVERED IN THE SESSION:
WHO SHOULD ATTEND:
Any member of a cross functional project team:
This course crosses all industries and functions it is however particularly suited for the health sciences and other regulated industries where much project-based work is accomplished. The types of industries that are targeted include:
An In vitro diagnostic project manager is responsible for overseeing the development and launch of a new diagnostic product. There are many steps and processes involved in the development of an IVD product, including research and development, clinical trials, regulatory approval, and manufacturing.
The project manager must have a thorough understanding of the project management process and how it integrates into IVD development to ensure that the project stays on track, on time, and within budget. This includes developing a project plan that outlines all the tasks and timelines necessary to complete the project successfully. The project manager must also be familiar with the regulatory requirements and standards governing IVD development, such as ISO 13485 and FDA regulations.
This knowledge is essential to ensure that the product is developed to the required quality standards and is compliant with regulatory requirements. Additionally, the project manager must work closely with cross-functional teams involved in IVD development, including research and development, clinical affairs, regulatory affairs, and manufacturing. Effective communication and collaboration are critical for the project manager to ensure that everyone is working towards the same goals and objectives.
A thorough understanding of the project management process and how it integrates into IVD development is critical for an In vitro diagnostic project manager to ensure the successful development and launch of a new diagnostic product.
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.