Clinical trials manager

The clinical trials manager is the person of first contact for all trial-related matters and is usually responsible for much of the drafting of the protocol, for clinical report form design, and instituting randomization procedures, in addition to the day-to-day running of the trial. For a multi-centre trial, duties are likely to include visiting and recruiting centres, setting up databases, managing data, dealing with queries, maintaining mailing lists, organizing meetings, preparing newsletters, and reporting on progress to collaborating centres and the data monitoring and ethics committee. The clinical trials manager is thus the key and essential person responsible for the practicalities oftrial management on a day-to-day basis, and it is invaluable to have an experienced person in this role.

For a large or data-intensive trial, it can be useful to appoint a further person or persons who works with the clinical trials manager and maybe responsible for data entry, data management, maintaining the database, chasing up overdue data, and for raising queries about data with collaborating centres. Many trials will also require computing (see Section 8.11), administrative and secretarial support.

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