Project/Delivery Management

I have experience of a variety of formal project management methodologies. Elements of all of these can be applied to projects in the life-sciences environment - taking an eclectic approach which ensures projects are suitable for the circumstances.

• DSDM^™: (Dynamic Systems Development Method) is a project management methodology developed and published on behalf of a consortium of (predominantly British) companies but now gaining acceptance world-wide. It is an iterative and incremental approach which advocates a high level of customer involvement. It uses time boxing and MoSCoW (Must have, Should have, Could have if time allows and Won't have this time) priority setting to achieve the best, timely result for the customer. See http://www.dsdm.org for further details.
• Prince2^™: PRojects IN a Controlled Environment - developed by the Office of Governmental Central Computer and Telecoms Agency (CCTA) now Office of Government Commerce (OGC), it is rapidly becoming the de facto standard for project management in the UK and abroad. It is based on 8 high level processes such as Starting up a project, Planning or Controlling a Stage together with 8 components such as Organisation, Plans or Change Control. It is a staged or phased approach, the stages following each other and not starting until the previous one is properly completed - this does NOT mean it is a waterfall approach and it is normally applied iteratively. Again customer involvement is high.
• RUP^™: The Rational Unified Process was originally developed by Rational Software Corporation which is now a division of IBM. It is a Framework which can be customised, particularly suited to large projects. Fundamental to its use are Use Cases which describe the desired behaviour and the tools used to support the process. It describes four main phases to a project; Inception, Elaboration, Construction and Transition and like DSDM it is an iterative technique.

Planning tools

Synonymous with Project management is the use of Microsoft Project for producing the "Project Plan" - in many cases the Gantt chart. At a minimum this also needs to be coupled with change, risk and issue management and test planning (amongst others depending on the project). Many of these can built using the standard Microsoft Office tools such as Access and EXCEL.

My in-depth knowledge (including programming automation with Visual Basic) enables the right effective communication vehicles to be produced.

Off Shore Developments

A predominant feature of many projects nowadays in an element of off-shore development, utilising lower cost resource in India, China, Russia or other eastern block countries. This brings it's own challenges which I have several years experience dealing with, ensuring effective delivery in terms of cost, budget and quality. Making sure you realise the benefits of using off-shore teams.

I have worked successfully with teams based in India and Russia

Meeting Facilitation

Meetings are a very expensive, but essential way of communication in a project team. It therefore makes business sense to ensure that any meetings on a project are efficiently conducted. Does everyone in the meeting contribute effectively? Is the outcome clear, agreed and documented? This is where meeting facilitation can help. One of the much abused techniques for meetings is "Brain Storming" to do this properly requires a facilitator, with knowledge of the domain but without prejudice or vested interest in any particular outcome.

Computer Systems Validation

Validation of Computer Systems according to GxP standards in an audit-able manner is business critical in Pharma Development and Post Marketing. It is the process assuring, in a traceable and documented manner that will pass subsequent audit by regulators, that a computer system does exactly what it is designed to do (meeting the requirements) in a consistent and reproducible way. The risk based approach adopted by GAMP^® can be applied to focus the validation and hence reduce time-lines without compromising quality.

I have been responsible for at least 15 Validated, GxP compliant, "Go-Lives" in Pharmaceutical companies and am a member of the Research Quality Association.

Web based technology

Almost every projects nowadays employs some form of internet/intranet based technology. From a project management viewpoint it is important to understand the technology used by your project. I have either direct hands on experience in the use of many technologies (HTML, XML, JSON, ASP, Php, SQL Databases), having used them directly to develop systems myself, or a good understanding from a management viewpoint (SOAP, .NET, Web Services).