Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on, in-person training. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses take place at state-of-the-art corporate meeting centers or in centrally located hotels on the East and West Coasts of the U.S., and offer focused, performance-based training and employee development.
Clinical Project Management: Advanced Concepts in Project Management
This course offering will take place live via WebEx from 12:00 PM – 7:00 PM Eastern each day. Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.
This course provides the experienced Clinical Project Manager (with a minimum of three years in either the pharmaceutical, biotech, biologics or medical device industries) the advanced clinical project management and leadership skills to effectively lead project teams to their optimal performance. This two-day course builds upon advanced clinical research project management skills benchmarking, to Project Management Institute, PMBOK® concepts as they apply to clinical project management, including effective use of the project manager’s communication and leadership skills to overcome difficult issues a project manager may encounter. Advanced concepts will be presented to explore how project managers can effectively: Prioritize project needs, influence, lead project teams and stakeholders, and utilize best practices for documentation of project and team decisions. Operational challenges will also be explored including vendor lifecycle management, assessment of risk (project, quality), issue management with the use of root cause analysis, and corrective and preventive action (CAPA) plans for effective management. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.
- Explain project management tools and principles used in clinical trials
- Formulate project priorities and approach to effectively manage project needs
- Appraise effective use of communication and leadership skills for the project needs
- Manage projects and quality risks
- Appraise effective stakeholder and vendor management in clinical trials
- Describe effective leadership skills in leading project teams
Who Should Attend
- Project Managers
- Clinical Research Coordinators, Associates, Monitors, and Managers
- Regulatory, Medical, and Clinical Affairs Professionals
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., ACRP-PM., P.M.P.
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction: Review of clinical project charter, project plan, project risk analysis, and use of various tracking methods in project management
- Importance of the Project Team: Your team is the key to project success
- Prioritization Management: Priority setting to manage project schedule and workload
- Managing Projects: Stakeholder management and effectively leading/directing/influencing project teams
Day Two: 8:30 a.m. – 5:00 p.m.
- Managing Projects and Quality Risks: Risk management, issue management, root cause analysis, CAPA, and documentation
- Project Vendor Management: CROs, CRO sub-contractors, commercial IRBs, core laboratories, Data Safety Monitoring Boards, Independent Physician Adjudicators
- Case Study: Prioritization management
- Case Study: Effective leadership skills, per the topic or situation encountered
- Practice: Effective negotiation skills and stakeholder management
- Case Study: Identify risks in vendor management
- Case Study: Stakeholder and vendor management
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.
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#: 0778-0000-21-002-L04-P. Released: 4/21.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.