Clinical trial lead is the manager of the site and also the head of the project. CRA and trial managers can work as clinical trial lead, and they have several responsibilities to perform. Some of the responsibilities of clinical trial lead are given as below:
1. Supervising clinical team:
The management and supervision of the clinical team is the primary responsibility of the clinical trial lead. This clinical team includes clinical research associates, clinical monitoring associates, and clinical trial associates. The responsibilities of the clinical team are to schedule their site visits, calling their sites and to reconcile the trial master file. Clinical trial lead is the one person who leads this clinical team and has to look after if his team is effectively fulfilling their duties and responsibilities.
2. Clinical study plans:
Clinical monitoring associates has to monitor the procedures and protocols of clinical trials, and the clinical trial lead is involved in this monitoring as a head. Clinical trial lead is engaged in every clinical activity, whether it is a TMF plan and is responsible for results of clinical trials.
3. Managing TMF:
Clinical trial lead has to manage trial master files as a head of the clinical site. TMF needs to be in order to continue the study. This TMF includes many documents that are compulsory for the study, and these documents have to be in order that is the responsibility of the team lead.
Clinical trial lead has good management skills because they have been working for years as clinical research associates and project management side of things.