Risk Management for Project Managers


Current clinical research standards like ICH GCP E6 R2 and ISO 14155 expects researchers to apply risk-based approaches for the management of clinical trials. In practice, this entails adjusting your planning for project resources, budget, communication, monitoring, quality management, vendor management and archiving to the project’s risk management plan, of which the risk assessment log is an important part. You will learn how to write a tailored risk management plan and complete a risk assessment log that you can use to manage your trial per priority. Further, emphasis is on the impact of a risk-based approach on the budget, timelines and vendor management & oversight since these are the biggest hurdles for most PMs to overcome in practice.

We offer this through recording and in a classroom setting. The latter includes exercises.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Set-up a risk management plan and related metrics
  • Assess CRO (vendor) competence related to risk management during CRO (vendor) selection and ongoing
  • List what risk related information to share and not to share with CROs (vendors)
  • Detect and escalate red flags and issues timely and accurately
  • Ensure the risk-based approach is considered in your project plans, trial related budgets and timelines
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Esther Daemen
Esther Daemen has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”