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| | | Here is a selection from many interesting assignments over recent years. These are only brief summaries. There are details of recent studies managed under Clinical Trial Experience (links on the left). There are also some consulting case studies under Project Management, and some more detail on major medical writing assignments.
- Setting up a project management methodology for a health economics consulting company. The requirement was met with a mix of modular half day training sessions, one to one working with the project planner, off-site development of planning tools, templates and procedures, and round table feedback sessions with directors and functional leads. One year later, project delivery had improved, with lower costs, and lower stress levels! The improvement was maintained two years later. There are further details in a case study which you can reach via the menu on the right, or by clicking here.
- Building project planning and control tools for a health care products company. Tools included a library of planning templates in Microsoft Project, which could be used for new studies with minimal customisation. A key issue was financial control. Phased budgets within MS Project were set up, interfacing to modules in Excel which could do more detailed processing (eg cash flow forecasts).
- Upgrading project management practice for a pharmaceutical industry data services company. Working alongside the project support manager, I developed improved methods of workload management. These interfaced between Microsoft Project and some legacy systems used for planning resources. A complete library of updated planning templates was delivered. All project managers were brought to a common standard of competence with a two day customised training course, which in particular addressed key cultural and organisational issues. Click here for a case study.
- Team leader for a safety data recovery project. The work involved scientific review and oversight for consolidating and extracting data across a large number of study databases.
- Market feasibility study for a contract research organisation. A survey of potential clients was designed and carried out, including one to one interviews with 22 respondents. A 22-page report was prepared, covering market volume and growth, segmentation, and competitors.
- Content for an electronic training system. The client, an e-learning company, required expert input to develop material for clinical project managers. The main focus was on financial control. Key project management techniques covered included project definition, estimating, risk management, and committed cost control.
- Trial master file audit for international vaccine studies. This involved review of records for 20 studies in Europe and the Middle East, as one of a team of auditors. A database system was set up for tracking essential documents.
- Advice on selection of an Electronic Data Capture vendor. This involved sitting in on vendor presentations (providing critical input), reviewing offerings from technical and regulatory standpoints, and advising on contracts. Intellectual property (IP) issues were a major consideration, eg whether the vendor had title to the software, and the need to place IP rights into escrow to ensure that the project could be continued in the event of vendor default or financial failure.
- Current awareness service for a medical communications company. Short critical reviews of published papers were written, based on monthly literature searches from which selections were made according to relevance and interest for the client. This work continued for over six years, covering a range of therapeutic areas.
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