Project Management

According to the Business Dictionary (2010), ‘project management’ is organisation of work within time, budget and cost limits. A bad project manager, therefore, can be defined as a manager who is unable to arrange project work according to some or all of these constraints. The reasons for this may be a PM’s lack of experience/knowledge or skills and poor communication between concerned parties (which is also due to insufficient training, SOPs, lack of experience or inability to account for previous failures and success).


As highlighted by Rettig, R.A. (2000, p.129), the importance of project management and oversight is crucial in the environment of prevailing commercial approach in pharmaceutical industry. Though it may be safer for Pharma to manage their own R&D projects internally, it becomes more time- and cost-effective to outsource clinical trial and pre-approval activities to specialized CROs. However, it is true that quality of project management services delivered by CROs is often unsatisfactory due to different reasons (Bryde, D.J. and Joby, R., 2007). Among other reasons for such outcome the authors cite the view of British Standards Institute (2003), according to which project management is a service that must be of an appropriate quality, i.e. must satisfy all participating parties. However, projects (even very similar in many aspects) are also unique and, thus, require individual approach based on previous experience.




Indeed, reasons for failure of a project and most significant elements of project success can be defined as symmetrical antipodesIf one would define what a bad project manager could do wrong to cause a project failure, it is possible to mention instead what a good project manager would do to make a project successful. The most important elements of a successful project management are Quality Assurance and project planning at each step. So, to avoid problems in project management the following must be taken into account by project management team (or a PM):


Houston, S.M. & Bove, L.A. (2007):


  • Consistent methodology
  • Definition of a project by limits of time, cost and performance (OR by scope, cost and time)

EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.468):

  • Team with sufficient knowledge and training
  • Support and back-up of the organisation

Wycoff, 1991 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.469):

  • Understanding that project is feasible:
    • Knowledge that you, as a PM, can achieve/facilitate achievement of the project            goals
    • Planning: a clear picture for all participants to describe the stage of the project, how  a certain goal was achieved and where/how to move further to reach further goals
    • Utilization of project management frameworks, such as PRINCE (EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S., 1997, p.469)
    • Assessment and re-assessment of risks = development and subsequent adjustment of the initial project plan

Besides, a good project manager would ask him/her-self the following questions and make the answers clear to other team members (Caan, W., Wright, J. & Hampton-Matthews, S., 1997):

–          Why certain steps are maid = what result is expected

–          What is required for goals achievement

–          Who should do what and when: Development of the Communication Plan

–          Whether everything needed is in place to start

–          When and whether the project is completed

–          What lessons have been learnt from this project

–          What can be done to improve further performance

So, to make a project successful a PM must: be experienced, have appropriate team and support, plan accordingly, communicate, make corrections, learn from previous mistakes/success, implement gained knowledge.



Bryde, D.J. and Joby, R. (2007) ‘Importance of project and project management deliverables in clinical trials’, R&D Management, 37(4), pp. 363-377.

Business Dictionary (2010) Project Management [Online]. Available from:

Caan, W., Wright, J. & Hampton-Matthews, S. (1997) ‘Start as you mean to go on:  Project management for beginners’, Journal of Mental Health, October, 6(5), pp. 467-472.

Houston, S.M. & Bove, L.A. (2007) Project Management for Healthcare Informatics, Springer (New York), Chapter 1 ‘Project Management Process’, pp. 1-14 .

Rettig, R.A. (2000) ‘The Industrialisation of Clinical Research’, Health Affairs, Vol 19, Issue 2, pp. 129-146.

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