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ASPE 2010 Catalog

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Course H350
Clinical Project Management

Strategic Project Management For Clinical Drug Development: Maximize Efficiencies, Meet Milestones, and Deliver On Target

In two days, quickly master:

  • Managing the complex clinical project
  • The development schedule
  • GCP Guidelines/FDA Regulations
  • Strategic alliance management
  • Clinical "Phase-to-Phase" planning
  • Product licensing strategies
  • Real-world tools/applications
  • Project & clinical development plans
  • Marketing authorization application
  • Tracking issues/contingency planning
  • The product launch label

Solid Project Management Skills…Your Success Depends On It!

To remain competitive in today’s challenging and uncertain markets, pharma and biotech companies must continually
pursue innovative products. It’s that simple. Successful
completion of challenging clinical trials is a must for project registration. The growth and success of your organization depends upon it.

Your clinical trials require huge investments of time, resources, and money — all with no guarantee of success. Efficient and effective management of clinical trials is an invaluable way to optimize the impact to your resources
during development of drugs, biologic, or medical devices.

Enhanced Project Leadership Abilities In A Comprehensive Two-Day Program

This two-day course contains the best-proven industry strategies and the most important lessons learned, taught to you in an interactive hands-on workshop that will leave no stone unturned. You’ll identify the methodologies and techniques to deliver risk-managed, cost-effective project leadership skills which are imperative for development.

Using Project Management processes and skills, the challenges faced with strategic clinical development will be addresses, head on. Both practical and tactical strategies for today’s drug, bio product, device and life science organizations will be covered.

15 Immediate Benefits of Attending this 2-Day Clinical Project Management Program

  1. Improve your ability to plan, implement, monitor and control clinical development projects
  2. Better lead and manage a team through the stages of clinical investigation to prepare the team to develop a transition strategy to move into the next phase of clinical investigation
  3. Learn how to track, report and resolve issues, proactively evaluate project activities, build contingency plans, execute corrective actions and develop risk mitigation plans
  4. Develop effective tools to maximize efficiencies, deliver on targets and milestones
  5. Demonstrate the strategic advantage of the project management function to the organization at large
  6. Learn straightforward, actionable advice on Clinical Project Management best practices for novice managers, seasoned leaders and professionals at all levels
  7. Know how to proactively manage and effectively develop strategic partners
  8. Develop skills and discover effective tips and tricks to effectively manage cross functional teams
  9. Learn to track, report and resolve technical and team issues at all levels
  10. Positively lead your team in a collaborative way to manage clinical trials
  11. Employ effective planning techniques to help develop clinical development risk mitigation plans
  12. Thoroughly prepare your teams to develop and review regulatory compliance strategies
  13. Lead your team to review and manage the product label and target profile document
  14. Prepare and lead the team for the Investigational New Drug Application (IND) and the Marketing Authorization Application (NDA)
  15. Manage responsibilities and risks without sacrificing speed and accuracy

Course Outline

Key Deliverables - Quantifiable skills you will take away:

Clinical Project Management Process

  • Produce the development schedule: the key to success
  • Manage, monitor and control clinical trial timelines and budgets
  • Prepare, plan and manage the product licensing submission

Transitional Phases and Development Milestones

  • Managing development milestones
  • Define, plan, manage, and verify scope of a clinical trial
  • Plan for transition from phase to phase
  • Identify the processes for planning, executing, & monitoring
  • Control and close out a complex clinical trial

Regulatory Compliance

  • GCP guidelines and FDA regulations
  • Manage quality of complex clinical trial

Working with Contract Research Organizations (CROs)

  • Manage strategic partners
  • Manage outsourced aspects of project
  • Strategic alliance management


Topics in Brief

I. Develop and refine the product launch label
Direct your team to manage the clinical development plan with the label in mind, assuring efficient use of resources

II. Develop an effective project plan
The project plan encompasses not only the clinical plan, but also the risk, communications, regulatory and other plans to assure an effective project enterprise

III. Apply process improvement techniques to your project management discipline
Learn the areas of greatest project risk and implement improvement initiatives

IV. Incorporate the Regulatory Strategy of the project into the development of you product
A key critical success factor in the development of you product is a successful regulatory approval. How do you manage Regulatory strategy into your development plan?

V. Work with project stakeholders to develop project requirements
Integrate all members of the project team, company stakeholders and management to understand the strategic as well as tactical aspects of the project

VI. Maintain effective working relationships with all project stakeholders
As part of the communication plan, develop a ongoing dialog with team stakeholders

VII. Develop a submission plan
What is your regulatory submission strategy? What is your plan for an NDA submission?

VIII. Develop better relationships with clients and management
Develop skills as a project manager to lead the development of the project and become a key stakeholder for the management team

IX. How to manage and develop a solid relationship with your strategic partners
Learn the skills of managing external partners for the greater good of your project. How to incorporate them into your team’s culture

X. As part of your project plan, incorporate a regulatory response strategy
Implement a regulatory response strategy to proactively prepare for your pre-approval questions

XI. Develop an effective project risk strategy and mitigation strategies
Learn how to effectively manage risk and how to develop risk strategies

XII. Manage meetings that bring about results
Implement an effective meeting strategy that delivers results and effectively communicates strategy with all stakeholders and learn the differences in holding on-site meetings and virtual meetings

XIII. Learn the nuances of working with 3rd party contractors
Develop a strategy for working with 3rd party strategic stakeholders and assure alignment of deliverables meet the needs of the team

XIV. Develop an effective communication plan
Work with the key stakeholders to develop the communication plan that aligns with the team and company management

XV. Communication tactics that create cohesion and unity and prevent costly miscommunication
Learn how to effectively communicate with all team members, including internal stakeholders, management and external partners

Case Studies and Group Exercises

With your peers, in class, develop real-world case studies that yield skills and better management techniques:
  • Develop a draft launch label
  • Develop a communication plan, providing necessary information to project stakeholders: staff, analysts, managers, physicians, clinical study sites, leaders, external partners and internal team members
  • Customized case studies, tailored to class needs will be developed for each program
  • Build a project plan to develop a small molecule, integrating work from functional areas, leading up to and the delivery of a New Drug Application submission to the Food and Drug Administration

Who should attend

Gain a better, more complete understanding of the strategic importance of the Project Manager in the clinical development process.

This two-day program has been developed to help the professional make better decisions and enhance management skills to result in the best outcome of the clinical development process. Whether new to the field or a seasoned professional, all will benefit greatly. Those who will benefit include:
  • Clinical Project Managers
  • Personal Research Associates
  • Investigators
  • Clinical Trial Managers
  • Medical Affairs and Clinical Operations Professionals

Instructor-Developed Course Documentation

Created for the specific needs of the clinical drug development profession.

Participants will enjoy this comprehensive PM program specifically developed to address the issues of the clinical drug professional, both in the trenches and at all other levels of the project. Courseware will round out your learning experience and become a valuable reference back at the worksite. You will receive previously unavailable information included throughout the documentation on techniques, tips, examples, and case studies. Also get a roadmap to a better and more controlled clinical development methodology for your organization.

This program is designed to address your specific clinical drug and medical device development needs. Attend this program and learn to manage the full spectrum of responsibility and risk for any life science development projects.