Hope Cullen, Author at Imperial Clinical Research Services Blog

Effective clinical trial project managers do more than just keep tasks on schedule; they play a crucial role in ensuring project success and operational efficiency. Organizations that adopt project management practices achieve a 92% success rate in meeting their project goals and experience 28 times less financial waste than those without proven methodologies.¹ Skilled project managers are essential for controlling costs, meeting deadlines, and ultimately ensuring the overall success of a clinical study.

The estimated mean cost of developing a new drug from 2000 to 2018 was $172.7 million (2018 dollars). That price tag increased to $515.8 million when the cost of failures was included, and to $879.3 million when both drug development failure and capital costs were included. Clinical trials comprised the largest portion of overall drug development costs at $117.4 million, which accounted for about 68 percent of out-of-pocket R&D expenditures. ^2,3

One survey shows that for every $1 billion invested in a project, more than $122 million is wasted due to poor project performance.⁴ That’s a substantial 12 percent.

Consider how that number impacts the clinical trial industry.

What is a project manager?

Being put in charge of a project does not necessarily make someone a project manager. Project management is not simply the practice of applying logic or common sense. A project manager should systematically apply specific knowledge, skills, tools, and techniques to project-based activities to meet project requirements.

The project manager is the link between strategy and execution, which is a true strategic discipline. On the strategy side are stakeholders, champions, and business leaders, who communicate the vision and the objective. The clinical trial project manager must then bridge the gap between those strategists and the team members who are working to accomplish these goals. That link is the project manager’s main function.

The Five Steps of Project Management

There are different types of projects, and a clinical trial as a project is considered large-scale and complex. Clinical trials contain many components, such as study startup, recruitment, labs, investigational product, data, materials, and site management. These are actually considered sub-components and sub-projects within the clinical trial project as a whole, and they need to be fully managed with the same project management disciplines. There are five phases of project management: ⁵

Initiating: Define the project’s objectives, scope, and feasibility; identify stakeholders.
Planning: Establish and define the total scope of the project (including boundaries and deliverables to prevent scope creep), build timelines, identify potential risks, milestones, stakeholder management, and budgets. Planning is a significant portion of the project.
Executing: Acquire, develop, manage, and collaborate with teams, perform quality assurance, manage communications, engage stakeholders, and attain goals. Complete deliverables to achieve project goals.
Monitoring and controlling: Make adjustments along the way and determine if the project needs to be terminated, adjusted, or continued. Control project work, scope, schedule, cost, communications, and risk.
Closing: End the project using a formalized process. This could include a review or audit of how the project went and lessons learned.

These process groups are the lifeblood of every project and the responsibility of the project manager.

Proactive Clinical Trial Project Managers Are Key

Some project managers are great employees, but were put in the role with no project management training and/or experience. Other project managers have some project management training and experience. They understand the basics of project management and the five process groups, but tend to have a reactive approach.

One of the most common reasons clinical trials fail is inadequate project management.⁶

clinical trial project management Proactive project managers have project management training and experience. They understand the five process groups and utilize them in all their projects in order to ensure appropriate project execution.

These project managers also use all their skills, including interpersonal skills and project management tools and techniques, to proactively anticipate and handle project movements. They exercise foresight, make good decisions based on their experience and training, and communicate effectively with all parties at all stages of the project.

An experienced clinical trial project manager with a sound skill set and process discipline can be the difference between project success and project failure. Clinical trials are a significant investment. Investing in the “right” project manager will almost surely reap dividends in trial execution.

Effective Clinical Trial Project Managers

Many proven tools exist for project management success, and these four are key:

Communication
- Formalized communication plan
- Listen and understand issues
Leadership
- Motivate and influence team members
- Empower others
Negotiation
Project management discipline
- Project management organizational system
- Analyze data
- Manage risk
- Continuous project management training

The success of clinical trial project management relies on a combination of software tools, methodologies, and personal skills. And success relies on managing tasks, tracking progress, and facilitating team collaboration. Additional resources, such as project management certifications and informal ongoing project management training, can also significantly contribute to successful project outcomes.

At Imperial, effective project management is the cornerstone of our business, and the client experience is a major part of the project manager’s responsibility. Accomplished project managers are essential for controlling costs, adhering to timelines, and ultimately ensuring the overall success of a clinical study.

The information in this blog is taken, in part, from our second edition ebook Effective Project Management for Clinical Trials: A Business Approach. This ebook gives more detailed information and a closer look at effective clinical trial project management. It will be available for free download next month. Follow Imperial on LinkedIn for notifications of its release or visit our website. You can also download our free project management ebook, tailored to ancillary supplies and equipment management Ancillary Supplies and Equipment for Clinical Trials: A Project Management Approach.