Chris Lee

Have worked in the Pharmacuetical Industry for over 15 years firstly as a senior manager in feasibility and more recently as a Regional Contracts Manger. Have a good understanding of ICH GCP and legal implications realated to contract management.

I live in Scotland but for the last few years have been based in London. I am married with 6 children. Enjoy cycling and keeping fit having just finished a 3 day cycle ride from Zurich to Munich.

Dedicated Regional Contracts Manger (RCM), working in related roles since early 2002 spanning Phase I-IV and noninterventional studies. Responsible for assessing risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provided advice to Contract and Grants Analysts, stakeholders, and others within my role as ISS (ICON Strategic solutions) RCM. Was instrumental in setting up RCM team response to GDPR and providing fallback language for the Contracts and Grants group. Broad background and good understanding of clinical trial conduct and management from both a practical perspective and from an organizational, legal and feasibility point of view. Worked on over 500 escalations across EMEA in the time working for ISS to analyse, manage and expedite resolution of complex legal issues. Have a vast amount of experience in GCP, GDPR, IP having worked in a GCP environment up to senior management level as a feasibility manager (early phase unit), working as an EMEA contracts manager being instrumental in setting up fallback response for GDPR and developing the team and having IP qualification from Queen Mary University of London and Chartered institute of Patent Attorneys, London.

Queen Mary Intellectual Property Research Institute, University of London, UK, M.Sc., Intellectual Property Law, 2003 

Chartered institute of Patent Attorneys, London, UK, Certificate in Intellectual Property Law, 2003

Project Mangement for Research Professionals - International Academy of Clinical Research