Transforming a Clinical Operations department to achieve operational excellence

Situation

The Clinical Operations department consisted of 20 local affiliates that are accountable for the execution of clinical trials. There was no system in place to plan capacity, share resources, re-distribute work, measure performance or drive improvement initiatives, resulting in inefficiencies, high costs and delays in trial execution.

The Leadership Team set an objective to improve operational efficiently to deal with resource limitations and budgetary constraints, while ensuring fast execution of clinical trials and adherence to regulatory standards.

Approach

As head of the Operational Services department, I led the transformation by:

- Implementation of a collaboration model for the 20 EU affiliates - Introduction of a capacity planning model to accurately forecast resource demand and used that to optimize country selection and resource allocation. - Established standard KPIs for performance tracking and led improvement initiatives

Outcome

Improved communication and collaboration between the affiliates.

Optimized country selection and resource allocation resulting in lower operational costs. Better performance tracking to support efficient trial execution and compliance.

How long did it take

24 months

Cost

The project was executed with internal resources

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