Instead of terming this a skill set, I would recommend a project lead who is well versed in FDA, EMEA, and government regulations, for a start. Trials of scheduled drugs [drugs whose use and distribution are tightly controlled] must be managed according to a well-documented set of regulations, which are very specific in detailing the clinical supplies requirements. Because of the risks these products pose in terms of addiction or street resale value, there is a high risk of diversion and regulations are designed to prevent any possibility of this occurring, which makes our focus to simply follow very prescriptive guidelines.

For example, FDA regulations mandate that any scheduled drug that enters the European Union must stay in the original country to which it was delivered. No redistribution is possible. Trials such as these require scrupulous advance planning and then flawless execution.

That being said, the skill set required these days to manage any large clinical program is best suited to individuals who are highly analytical, detail-oriented, and strong communicators. Successful project execution in today’s environment requires a thorough logistical understanding, knowledge of risk assessment and mitigation planning, multi-cultural awareness, and leadership competencies.