Theoretical concepts from the Project Management Institute, PMBOK® are introduced in this introductory project management course for the clinical research professional working in the pharmaceutical or medical device industry. Whether you are looking to become a clinical research project manager, are already in an entry-level project manager role, or a project manager without formal project training, this two-day interactive course hands-on program will provide you with project management skills, tools and processes required to successfully manage projects in clinical research settings. Case studies, discussion, and interactive activities are utilized to aid the learner in application of clinical project management concepts and principles.
- Describe project management as it applies to clinical research and in the management of clinical trials
- Identify how project managers develop high performance project teams
- Develop a project plan and work breakdown structure
- Identify process mapping tools used in clinical research
- Recognize the importance of effective project schedules
- Identify clinical trial project budgetary needs
- Identify performance metrics and utilize effectively to monitor project
- Management of vendors within a clinical trial for optimal oversight and outcomes
- Implement successful project closure and lessons learned
- Project Managers from pharmaceutical, medical device, or CRO industry with less than two years in the role of Clinical Project Manager or experienced Clinical Projects Managers without formal clinical project management training
- Newly Hired Clinical or Project Team Leaders who will be managing projects (either at the sponsor, CRO, or investigational site)
- Clinical Research Associates, Data Managers, or other members interested in transitioning into the Clinical Project Management role or 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.-PM., P.M.P.
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Day One: 8:30 a.m. – 5:00 p.m.
- Module 1: Introduction to Clinical Project Management: Overview of project management as defined by PMI®; roles and responsibilities of the clinical project manager; establishment of project teams
- Module 2: Project Planning: Review of the project charter; risk identification to clinical research projects; development of a project plan; creation of the work breakdown structure in a project
- Module 3: Process Mapping as a Planning and Management Tool: Why map a process; types of process mapping, creation of the process maps from trial planning through the final clinical study report
- Module 4: Effective Schedule Management: Defining project scope; creation of realistic schedules; identification of critical path to a project; effectively managing change orders and out of scope to your project
Day Two: 8:30 a.m. – 5:00 p.m.
- Module 5: Creation and Management of Budgets: Effective project budget planning and tracking
- Module 6: Project Tracking: Effective tracking of project; identification and establishment of project metrics; effective project meetings with your team
- Module 7: Vendor Management and Oversight: Qualification, selection, and oversight of vendors in clinical research projects
- Module 8: Project Closure: Effectively closing a project and lessons learned
- Case Study: Creation of a Work Breakdown Structure (WBS)
- Case Study: Project Management Plan in Study Start Up
- Case Study: Projection of Budget for Clinical Trial
- Case Study: Vendor Management Effectively Addressing Performance Issues
- Review of Project Management Lifecycle: Team Members Roles, Responsibilities, Schedules
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#: 0778-0000-18-023-L01-P. Released: 3/18.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.