INTRODUCTION:

During these 2 Days’ of online sessions, Trainees will learn how to adapt their project management knowledge to clinical trials. They will see how to manage clinical trials, set milestones, do risk management, allocate staff and budgets, dealing with clients and contracts. Several components of successful project management such as the inte-raction between project activities and key decisions will be highlighted. This is a very interactive course with workshops, putting the theoretical concepts into practice.

KEY TAKEAWAYS:

• What are the fundamentals of Project Management? Which Project Management Techniques exit?
• The Project Manager (negotiation, delegation, dealing with clients, quality)
• The Project Environment (regulations, guidelines, SOPs)
• Clinical Trial life cycle
• The clinical development Plan
• CRO selection basics
• The definition and initiation of a Trial (scope, feasibility, CDP)
• The planning of the Trial (project plan, milestones, schedules, charts, risk management, contracts)
• The Project Budget (budget sheets, budget control)
• The execution of the Trial (monitoring and controlling, reporting, dealing with changes)
• How to manage a clinical operation team
• The closure of the Trial (archiving, evaluation, project failure reasons)

RECOMMENDATION:

Who can attend?

• Project managers (or related clinical research professionals) who have just entered the world of
  project management in clinical research.
• Senior Clinical Research Associates (CRAs)
• People who are interacting regularly with Project Managers and who want to understand the
  pitfalls of clinical project management.

TRAINER:

NELLE STOCQUART

Clinical Operation expert and trainer at Solutionelle. Experienced Project Manager and Instructor with a demonstrated history of working in the professional training & pharmaceutical industry. Skilled in Vaccines, Training Delivery, Software Documentation, CRO Management, Clinical Project Management, Risk Management, Risk Based Monitoring and Oncology Clinical Research.

With a master’s in chemistry Nelle Stocquart works since 2003 in the Clinical Research world. She was first an IVRS project manager for a Belgian CRO but then she wished gaining more experience on the field and became CRA for a top 5 international CRO where she got involved in many international phases II & III from early study stage till closure. She then evolved as project manager in pharmaceutical companies and CRO where she managed local and international studies from phase I to phase IV. She is now working for the Belgian government which is funding academic studies. Nelle has a lot of experience in project management, team management and people coaching. Training, Coaching, Education and Continuous Professional Development have always been the common pillars in her educational path and professional career. She speaks fluently 3 languages (Dutch, French and English).