The Project Management Method

• Project Management as a management methodology
• Working through cross-functional pharmaceutical project teams
• Decentralized responsibility and authority
• How to build commitment and ownership of team members
• Nature of a Project as a way to get work done
• Management functions, roles, responsibilities
• Effect of national, corporate, and personal cultures/values
• What makes clinical trial projects different?
• Project and Line Management interfaces

  EXERCISE: Identifying Issues and Opportunities Related to the CRO
  Best practices for managing critical contract services, CRO's, and developing ownership and commitment of Project Team Members who come with various specialties and functions necessary for project success.
  
  EXERCISE: The Assessment Inventory of Project Management and Action Planning Kit™
  Participants will use this unique 360 degree evaluation tool to identify, benchmark and improve their Project Management Skills.

Project Planning

• Project tools used to initiate and plan the pharmaceutical project
• Sorting out and defining client (and stakeholder) requirements
• Value of verifiable project objectives
• Task assignments and requests
• Statement of Work (SOW)
• Work Breakdown Structure (WBS)
• Project organization and Linear Responsibility Charts (LRC)
• Scheduling the Project work; Gantt, PERT, CPM
• Resource requirements and personnel assignment planning
• Procurement and contracting methods and practices found useful
• The performance baseline, project budget
• Presenting the Project Execution Plan

WORKSHOP: Structuring and Organizing a Pharmaceutical Project
Participants share their experiences and apply the techniques in project plans and performance baselines for their projects. They evaluate the strengths and weaknesses of their approaches based on the information learned in the course.

Project Risk Management

• What is project risk, and what are the responsibilities of the project leader and project team for risk?
• International definition of risk terminology, and concepts
• How to develop a Risk Management Plan for the pharmaceutical project
• Techniques to identify risk, evaluate the probability and severity of risk, decide mitigating risk response, consider risk as an advantage, and develop a risk monitoring plan

WORKSHOP: Develop an approach to project plan risks using an effective technique to facilitate group action regarding risk identification, evaluation and response action planning.

Organizing and Staffing

• How successful companies organize to use project management effectively within their organization
• International trends using different organizational forms such as matrix, semi-matrix, product, functional and projectized approaches
• How the regulatory environment affects management of projects in the pharmaceutical, biotechnology and medical devices field
• Use of senior management committees in support of project management practices, project priorities and project portfolio management
• The concept of the project office and co-located project teams
• Policy to define, govern and support project management activities

Directing and Leading

• Essentials of project leadership
• How to build and maintain the project team as the "unit" of performance
• Effect of personal problem solving preferences on team performance, communications effectiveness and handling of conflict
• Practical tips to create high-impact communications within the team, with client and stakeholders, and with management
• How to conduct high-value project meetings and manage productive discussions
• What does the Project Leader do to motivate project team members and develop the necessary levels of individual and team commitment?

WORKSHOP: An assessment of your personal problem-solving style preference
Participants determine their personal problem-solving styles and learn techniques to build on their strengths and capitalize on contrasting strengths of colleagues' project, their project leader and their functional supervisor.

WORKSHOP: Project Situations
Participants are grouped in teams according to their problem solving style prefereces to solve typical project issues in a dynamic, interactive high-learning experience.

Controlling Project Performance

• Requirements for project control
• Control theory applied to people working
• Useful project management information system features
• How to control quality performance, schedule and budget
• Earned-value methods and activity-based task completion
• Measurement techniques - simple and effective
• Managing change in project deliverables, time and cost
• Six practical project control actions to create project success

WORKSHOP: The "Fine" Project
Participants apply control concepts to a typical laboratory task.

Reporting

• Using reporting systems with team and client communications
• How often, and how to create reporting for project progress
• Keeping the client informed-project status review principles
• How to design the reporting system
• Design of control reports

WORKSHOP: Creating a Management Reporting System for Project Control
Participants are grouped into teams to develop what they believe, based on the principles of practical project control, to be the appropriate reporting methods, formats and information required to best control pharmaceutical, clinical, R&D and medical devices projects.