National Occupational Standard for Clinical Trial Manager

Definition of Occupation

The Clinical Trial Manager (CTM) works for Clinical Research Organizations (CROs) and/or sponsors and is responsible for the overall management of clinical trials. Duties and responsibilities will vary somewhat between the two types of organizations. Depending on the organization, they may also be referred to as Clinical Study Managers, Clinical Study Leads, Clinical Team Managers, Clinical Operations Leads, Clinical Operations Managers, or Clinical Research Managers.

At a Sponsor organization that employs the services of specialized CROs, the CTM’s duties are more focused on providing the necessary oversight to ensure that the statement of work for the clinical trial and all contractual obligations are being followed by the CROs. At a sponsor organization that does not employ the services of specialized CROs, the duties and responsibilities will be broadly similar to the duties at a CRO.

The CTM is responsible for the start-up, implementation, conduct, and close-out of clinical trials. Start-up related tasks include but are not limited to the identification, qualification, and activation of clinical trial sites. The CTM reviews the study protocol and guidelines to ensure that country-specific requirements are properly outlined. The CTM may be accountable for overseeing submissions to regulatory authorities and Research Ethics Boards (REB).

Throughout the study, the CTM is responsible for the study progress (schedule, budget, resources, enrollment targets, etc). The CTM ensures that the study is well-executed by coordinating and collaborating with cross-functional teams and resources, managing external vendors (where applicable), managing risks, communicating with stakeholders, training staff, and resolving issues that arise during any aspect of the study (e.g., drug distribution, enrollment, site-level regulation, technical difficulties, interpersonal conflicts, etc.). Where plans need to be modified, the CTM proposes changes to minimize cost/schedule/scope variances.

The CTM may be responsible for overseeing the work of Clinical Research Associates (CRAs) and is involved in training them, reviewing their work, performing quality control visits, motivating the team, providing constructive feedback, conducting performance reviews, allocating work, and helping them to resolve issues.

How to use a National Occupational Standard

View summary NOS profile here: Clinical Trial Manager – National Occupational Standard Summary