This course provides the experienced project manager the additional skills they need to lead their domestic and international clinical trials to optimal performance. This two-day course builds upon basic and intermediate project management concepts, 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 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 in addressing vendor lifecycle management, assessment of risk (project, quality), issue management with the use of root cause analysis, and corrective and preventive action 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
- Choose the applicable good documentation practice approach in support of a regulatory inspection
- Project Managers, Directors, and Leaders
- Clinical Research Investigators, Coordinators, Associates, Monitors, and Managers
- Regulatory, Medical, and Clinical Affairs Professionals
- Preclinical and R&D Directors/Associates/Scientists
- Toxicology, Pharmacology, Pharmacovigilance, and Labeling Professionals
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: Review of clinical project charter, project plan, project risk analysis, and use of various tracking methods in project management
- Prioritization Management: Priority setting using Eisenhower's Urgent/Important Principle to manage time and workload
- Managing Projects when you don’t have authority: Stakeholder management, negotiation skills, and effectively leading/directing/influencing project teams
Day 2: 8:30 a.m. – 5:00 p.m.
- Review Key Concepts from Day One
- Project Vendor Management: CROs, CRO sub-contractors, commercial IRBs, core laboratories, Data Safety Monitoring Boards, Independent Physician Adjudicators
- Managing Projects and Quality Risks: Risk management, issue management, root cause analysis and CAPA
- Good Documentation Practices in Support of a Regulatory Inspection: Meeting minutes, effective use of decision logs, vendor oversight plans
- Development of a Personal Action Plan: Identify areas to utilize back at work and obtain instructor feedback on your designated approach
- 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: Choose good documentation practices to support a regulatory inspection
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# 0778-0000-15-002-L01-P. Released: 2/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.