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Management Forum

Clinical Research Project Management Training Course

To comply with ICH GCP R3

The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

26-28 June 2024
+ 23-25 October 2024 »

from £1099

Need help?  Enrol or reserve

Course Overview

Setting up and running clinical research projects is a complex process that needs effective project management. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. It is essential to manage clinical research projects within the set time frame, to budget and the right quality standard.  

With ever-increasing pressures on clinical research professionals, the use of project management can provide essential tools and techniques and be a key factor in the successful completion of such projects including bringing a drug or medical device to market – as demonstrated by the FDA critical path initiative.

This interactive three-day course has been designed to provide participants with a thorough understanding of both technical and interpersonal project management skills in clinical research projects. Interactive exercises are used to aid the learner in the application of clinical project management concepts and principles so they can easily use the tools to improve the success of existing or future clinical research projects.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending:

  • Acquire an in-depth understanding of technical project management methodologies and techniques to apply to clinical projects, including agile project management
  • Learn how to incorporate these project management processes into everyday working practices and your currentcl projects
  • Understand how to blend together both the technical aspects of project management and the essential interpersonal skills
  • Discover how to build core competencies to become an even more effective project manager
  • Discuss how to get the best results in a project team environment

Who should attend?

This course has been specifically designed to address the needs of clinical research professionals as well as those in the medical device and animal health industries.

The programme will benefit both newly appointed and established project team leaders/managers in clinical research wishing to refresh or update their skills.

The course will be of benefit to:

  • Aspiring and entry-level project managers, clinical trial managers and project team members
  • Clinical research associates
  • Project managers looking to gain experience in clinical research project management
  • Project leaders that are unfamiliar with project management tools and principles
  • Clinical research professionals transitioning to project management roles/functions
  • Clinical trial administrators
  • Medical advisers
  • Data managers
  • Clinical scientists
  • Academic and non-commercial clinical researchers
  • Regulatory authority professionals
  • Service providers including CROs and contractors

Enrol or reserve

The Clinical Research Project Management course will cover:

What is a Project / Project Management in Clinical research?

  • Defining the key characteristics of project management and their importance to Clinical research projects
  • Current and emerging ways to manage projects in clinical research including agile project management
  • Using a project management process for improving the success of your own clinical research projects
  • Sharing experiences and lessons learned from previous clinical research projects

Setting clear project objectives and defining the scope of clinical research projects

  • Aligning the project objectives with the strategic and financial business objectives
  • Defining the result, the cost and the time
  • The project brief or charter or business case

Creating the strategy for your clinical research projects

  • Understanding the importance of having an overall strategy for your projects
  • Develop and explore options
  • Strategic options for clinical trial projects

Detailed project planning of clinical research projects

  • Identifying the key project activities using a Work Breakdown Structure (WBS) and defining the work packages
  • Allocate responsibilities using the responsibility matrix
  • Planning a realistic schedule using Gantt analysis and setting clear milestones
  • Clinical trial regulatory and GCP activities – meeting quality expectations
  • Resource planning
  • Budget planning
  • Communication plan, Quality plan and the TMF plan
  • Contracts
  • Implementing risk management and contingency planning for your clinical research project
  • Project management software and tracking systems

Clinical Trial CRO and Service Provider Oversight and Management

  • CRO Oversight
  • Management of CROs/service providers on clinical research projects
  • How milestones measures and reviews are used to enhance visibility and deliver results
  • Good practices for managing outsourced clinical trial activities and projects

Patient/subject recruitment and retention

  • Improving patient recruitment and retention
  • Clinical trial diversity

Project implementation and control for your clinical research projects

  • Identifying the possible causes of problems in clinical research projects
  • Effective communication and how to manage stakeholders
  • Overcoming enablers and constraints of your projects
  • Implementing project control and reporting systems
  • Metrics and KPIs
  • Change requests 
  • Monitoring project activities, progress and performance

Project review and closure of clinical research projects

  • Close the project
  • Identifying the critical success factors and learning from mistakes for continuous improvement

Clinical research Pharma/bio leadership skills

  • Defining the role and skills of effective pharma project leaders
  • Leadership style
  • Improving your interpersonal skills as a leader

Motivate to achieve project milestones

  • Understand the principles and practices of motivation
  • Understand how to motivate different people and what motivates your project team
  • Completion of a self-evaluation questionnaire

Building pharma/bio clinical project teams

  • How to modify your leadership style to get the best results in a project team environment
  • Understand team management throughout the project life cycle
  • Building a high-performance team

Optimising project communication and cross-cultural communication

  • Effective communication and how to gain project buy-in
  • Preventing and overcoming misunderstandings and dealing with conflict
  • Communicating effectively with the project stakeholders including cross-culturally

Technology approaches to improve and speed up your clinical projects

  • Emerging industry initiatives for improving, accelerating, and managing clinical trial projects, AI applications.
  • Decentralized and hybrid trials

Clinical Trial Project time management

  • Identifying and managing common time-wasting activities in your projects
  • Maximising your prime time to improve your personal performance
  • Develop approaches to optimise time management

Enrol or reserve

Laura Brown
LB Training and Development Ltd

Dr Laura Brown is an independent pharmaceutical project management and training consultant. Laura has more than 25 years’ experience of managing clinical research projects in the pharmaceutical industry and has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has worked as a Life Cycle Project Manager, Clinical Research Project Manager and Head of a Training organisation in the Pharmaceutical industry. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including Project Management for the Pharmaceutical Industry.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

26-28 June 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14199

  • GBP 1,099 1,399
  • EUR 1,589 2,009
  • USD 1,821 2,289

Until 22 May

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Not ready to book yet?

for 7 days, no obligation

23-25 October 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14200

  • GBP 1,099 1,399
  • EUR 1,589 2,009
  • USD 1,821 2,289

Until 18 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

United Kingdom

  • Abbott Diabetes Care Ltd
  • COMPASS Pathways
  • Eisai Ltd
  • Jazz Pharmaceuticals
  • ROYAL MARSDEN TRUST

Belgium

  • SERVIER R&D Benelux

Italy

  • Invatec SRL

Switzerland

  • Medtronic International Trading Sarl

Enrol or reserve

Run Clinical Research Project Management Live online for your team

3 days

Typical duration

Pricing from:

  • GBP 1,200
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy