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Project management and the role of the Clinical Project Manager

The type of company or project management strongly influences the objectives to be achieved while remaining within the cost and time constraints For example, the management of a company or of a “silos” project appears in a traditional view of the coordination models, which highlights both the hierarchy and the vertical organization among the various departments (or parts of a project) , both the clear separation and the preservation of a single link in the chain, preventing an opening both in and out of the other sectors.

This kind of organisation has negative consequences on the achievements of the scopes, as the lack of communication and inter-exchange leads to a shift in priorities, from a wider interest in success to the narrower one oriented towards a small portion of the company or project phase, strongly limiting its implementation and realisation potentials.

Exploiting suitable methods and idea of an organisations, along with an involvement of the different elements constituting the transversal structural scheme, it is possible to solve most of the conflicts and overcome any obstacle deteriorating the working plan, obtaining successful projects in line with the objectives and general interests of the organisation and with the aim of concluding the project. All this contributes to the final results, so everything is important.

In a clinical trial, the role of the Clinical Project Manager (CPM) is a key figure for the management of a project.

In the specific case of a clinical project, the role of the CPM requires an ability of coordinating all the groups involved in the execution of a clinical trial, of creating conditions to develop a consistent strategy, ensuring a fluid communication flow of the critical aspects of all the steps (starting, planning, execution, monitoring and closing) and to transmit to the group members the ability of relating with the other chain links efficiently in order to ensure the realisation of the fixed goals.

A project includes SMART objectives, that – in the clinical environment – must be:

  • Specific in the direction of the trial;
  • Measurable in terms of change of the trial conditions, starting from a reference baseline;
  • Assignable in terms of tasks distributed within the team and realisable in a pre-established timeframe;
  • Realistic and compatible with the resources and deadlines available;
  • Time bound when establishing a date for the end of the project.

For the management of a clinical project to be fruitful, a feature of the CPM is to divide the workload according to a list of product-oriented (work breakdown structure): this tree structure is made of specific branches depending on the reference domain, and in the case of the CPM, part of the study protocol extending to aspects relating to:

  • introduction (background, literature analysis, objectives);
  • methodology (procedure, study design, follow-up);
  • data management (data collection and analysis, statistics, monitoring);
  • economic and insurance part (budget, patient insurance coverage)
  • others (QA, Informed Consent, Investigators’ CV etc.).

In conclusion, the figure of the CPM assures the achievement of the scopes described in the study protocol, as in an orchestra, with the ability of managing the different critical issues regarding the various steps of the project, intersection one with the other, and giving a global overview of the project itself.