Managing a Program for the Implementation of an integrated Data Hub for Clinical Development - SCALA Management Consulting

International
Pharmaceutical Company

Clinical Development

appr. 150

Project Members
(internal/external)

Team SCALA

2

Consultants

Time Period

15

Months

Managing a Program for the Implementation of an integrated Data Hub for Clinical Development

Starting Point

Clinical Development set up a program to replace the old system environment with a modern and holistic platform.
The main objective was to optimize the use of resources, accelerate development processes, and improve the evaluation and provision of information.
To relieve the program management and to speed up the program, the team was to be supplemented by an experienced program controller and an experienced quality manager.

Approach

Planning, conception and introduction of the Program Management Office (including the set-up of overarching processes and organizational structures, roles & responsibilities, methods & procedures).
Conceptual design and introduction of a cross-country and cross-divisional program controlling for the management of 4 sub-projects and staffing of the “Program Controller” (responsible for budget planning and monitoring of approx. 27 million EUR, resource planning and controlling of 4 sub-projects with more than 100 internal and external project staff, tracking of deliverables, risk management and managing of investment and operating costs (CAPEX/OPEX)).
Design and implementation of a quality management on program level and staffing of the “Program Quality Manager” (among others responsible for compliance with methods & procedures, monitoring of results as well as validation according to GxP guidelines).

Deliverables/Benefits

Professional and coordinated support in the areas of (financial) controlling and quality management.
Faster set-up times and know-how transfer by using senior consultants with many years of in-depth knowledge of the company.
Support of program management “from a single source”.

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