Project Management For Non-Project Managers Series - Project Management As Applied To Clinical Trials

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:

• Define clear project objectives and scope – This involves identifying the research question that the trial aims to answer, as well as the study population, interventions, outcomes, and endpoints. Defining clear project objectives and scope is critical for developing a comprehensive project plan, estimating resources and timelines, and ensuring that all stakeholders are aligned with the trial goals.
• Develop a comprehensive project plan – The project plan should include all activities required to conduct the trial, including study design, protocol development, site selection, participant recruitment, data collection, data analysis, and reporting. The project plan should also include timelines, milestones, and deliverables, as well as resource requirements, such as personnel, equipment, and budget.
• Establish effective communication channels – Communication channels should be established early in the trial and should include all stakeholders, such as sponsors, investigators, participants, and regulators. Regular communication updates should be provided to all stakeholders to ensure that everyone is informed of the trial progress, any changes to the protocol, and any issues or challenges that arise during the trial. 
• Implement risk management strategies – Effective risk management strategies should be implemented to identify, assess, and mitigate these risks. Risk management strategies should be included in the project plan and should be reviewed regularly throughout the trial. 
• Ensure compliance with regulatory requirements – Compliance with regulatory requirements should be incorporated into the project plan and should be reviewed regularly throughout the trial. Failure to comply with regulatory requirements can result in delays, penalties, and even the termination of the trial.
• Ensure data integrity and quality – Data should be collected and stored in accordance with regulatory requirements, and quality control measures should be implemented to ensure that data are of high quality.

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.

Learning Objectives:

• State the critical aspects of a clinical trial.
• State the key regulations that relate to clinical trials.
• List and describe the special aspects for considerations relating to clinical trials.
• List and describe the best project management practices for clinical trials.

Areas Covered In The Session:

• Anatomy of a clinical trial
• Special aspects of project managing clinical trials
  • PM responsibilities
  • Study preparation
  • Conduct of the study
  • Study closeout
• Clinical Trial PM best practices
  • Scope
  • Execution
  • Closeout
  • Special considerations

Who Should Attend:

Any member of a cross functional project team:

• Engineers
• Marketing Associates
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Associates, Managers, and Directors
• Manufacturing Managers
• Technicians

Anyone that participates in or has the potential to manage team-based cross-functional projects.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:

• Medical device manufacturers
• Pharmaceutical and Biotech organizations
• Cosmetic and foods manufacturers
• All other industries

Topic Background:

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.

Course Director: CHARLES H. PAUL

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.