This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed. There is specific focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management.
The training is focused on project management not on Clinical Operations.
- Develop a project plan
- Manage project timelines and costs
- Use project management tools effectively
- Build high performance project teams
- Gather performance metrics and use them to improve project success
- Set up the right environment to manage your contractors
- Monitor and control effectively a clinical study
- Manage project risk and implement CAPA
- New Project Managers
- Project Managers with little or no drug development or clinical trial experience
- Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New Clinical or other Project Team Leaders who will be managing projects
- Managers unfamiliar with clinical project management
- New Clinical, Regulatory, and Department Staff who will design clinical trial programs
- Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
The course will be led by one of the following instructors:
Marla Hoelle, R.N, B.S.N., C.C.R.A, P.M.P.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to Project Management: Overview of project management; roles and responsibilities of a project manager; establishing project teams
- Project Planning: Developing a project plan; project projections; analyzing risks and challenges; templating study activities
- Process Mapping as a Planning and Management Tool: Why map a process; types of mapping; dissection of the clinical trial process; creation of process maps from trial planning through final clinical study report
- Timeline Management: Understanding project scope; creating realistic timelines; monitoring the timeline
Day 2: 8:30 a.m. – 5:00 p.m.
- Management of Project Budgets: Creation of project budgets; ongoing financial monitoring
- Project Tracking: Tracking requirements; identifying and establishing project metrics; project meetings
- Ongoing Project Management
- Communication and Team Building: Team building; motivating and mentoring team members; conflict solution; communication strategies; effective communication skills
- Contractors – Managing Outsourcing: Factors influencing outsourcing; choosing a contractor; determining out of scopes
- Initiate the project and develop a WBS
- Perform a Network Analysis and develop the Critical Path of a project
- Monitor and forecast a project using EVA (Earned Value Analysis)
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-14-002-L01-P. Released: 1/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.