From time to time, I take on fixed term contracts as an interim manager. I enjoy leaving the client in a stronger position, in terms of management tools and techniques, than when I started.

Therapeutic area experience includes:

• Central nervous system - psychiatry, degenerative disorders, insomnia
• Cardiovascular
• Respiratory
• Rheumatology
• Anti-infectives
• Pain
• Metabolic - lipids, diabetes
• Oncology - palliative care, biologics
  

Getting the best from contract research organisations

• Prequalification
• Writing requests for proposals
  
• Selection including bid defence
• Contract production - eg providing new standard clauses covering performance targets.
• Quality management - commissioning CRO audits, negotiating corrective actions.
• Project management - setting up progress monitoring methods and keeping projects on track
• Change management - dealing with out of scope claims from CROs and using win-win negotiation to obtain a fair deal.

Planning for Results

• Using deliverables as the elements for planning deadlines and budgets.
• Setting realistic time scales and costs using win-win negotiation.
• Designing simple IT-based methods for progress control, which remote teams can use.

Getting multidisciplinary teams to work together – examples:

• Recruiting a project team for a new technical area, with academic and commercial members.
• Developing web-based methods for team communication and management.

Taking a strategic view of drug development

A recent example is the design for a client of an IT system for integrating all project planning, including milestones and budget control, from development plan level down to individual study level. This had the following main components:

• Project Progress Control. This included the automated linkage of progress information collected via emailed forms, to individual clinical trial projects and thence to clinical development master projects. Documents such as meeting agendas could be automatically generated.
• Budget Control. Outline costs defined in development plans (at NCE level) could be broken down to individual study level, generating such items as templates for CRO bids, and non-clinical costs (eg insurance). The system could track planned, committed and actual cost, and report appropriately.
• Human Resources. Workload estimates could be aggregated from individual study level to NCE level, right up to whole company level. Electronic time sheets (doubling as progress control) enabled actual work to be reported against plan.