Case Study - Project Management 1

A Pharmaceutical client requested help with the development of a medical device. Also to secure its manufacturing in Australia. This request came after the project had been underway for over 12 months. While many activities had been completed, global compliance requirements had tightened up in the meantime. Therefore the project needed to be re-set.
I facilitated a workshop to probe the timeline of events, consequences, causes, effects and regulatory changes. This allowed us to re-frame and re-plan the entire project.
Establishing a governance structure allowed visibility and alignment of effort and progress. This was necessary due to a multi-business project team, an internal core team and a sponsor reporting into the ELT. One-page A3 reports were prepared regularly to the sponsor.
The project ran over 18 months. As Project Manager I ran the fortnightly meetings with SME’s and local partners. We developed and conducted clinical trials to meet regulatory requirements.

Main benefits:

  • Getting key stakeholders in a room for one day, enabled all to unpack, reassess and create a timeline sufficient for the ELT to make an effective decision.
  • Running a tight project plan with appropriate levels of governance enabled traction on this project.
  • Working with a focussed team of specialist SME, ensured all potential risks were managed.
  • Clear reporting of complex clinical, production and medical trials enabled the ELT to keep pace with this project timeline.
  • This project gave me great insights into the complexities around medical device introduction into the Australian marketplace, and wonderful people that work in that environment.
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