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| home > epc > spring 2003 > common risks in clinical project management: a project manager's perspective |
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European Pharmaceutical Contractor
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In the current climate of financial uncertainty and unpredictability, risk assessment and risk management have become the financial buzzwords of the new millennium. For a clinical project manager, risk assessment and risk management comes with the territory. Every clinical project, be it a full development programme or a single clinical trial, has its typical risk factors. Regardless of the complexity of the project, budget overshoot, missed timelines, communication breakdown and staff turnover are often cited as generic project risks. Poor quality usually concludes this list, although it can hardly be separated out as a standalone entity. Project managers should have an insight into the origin of the most common risk factors if they want to be successful (1, 2). In particular, the first four should be well known to any seasoned project manager as he or she will be the first line of defence for sponsors looking to safeguard the project expectations. Understanding risk factors combined with experience often provides the most powerful risk management tool available - prevention.
Budget Overshoot
Various price settings possibilities exist in contract work, from an hourly price per activity up to a fixed price for an entire contract and any intermediate pricing format imaginable. If one is discussing 'the budget', it is often unclear what exactly is meant because the budget specifications, as stipulated in the contract, are not always unambiguously communicated to the project teams of either the sponsor or the CRO.
The CRO is often envisaged as the responsible party for budget overruns. However, both sponsor and CRO should be vigilant and assume their responsibilities to defer the demon of budget overshoot (3). The CRO's business development staff should know the 'tricks of the trade' of the services they are selling. All proposals sent out to a sponsor should have been reviewed and approved by the functional staff. Even when the proposal does list the assumptions it was based on, it is always good practice to state what the proposal does not include.
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