Agenda

Clinical Research Project / Program Management Virtual Conference


Please note - All times are in Eastern Time Zone. Times are fluid and may vary depending on the level of interaction


Day 1 - Tuesday 


1:00 - 3:15    Project Management - Developing an Infrastructure
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
Daniel Redline, BA, CCRP, Senior Director, Global Clinical Affairs, Align Technology, Inc. 

This session will provide an introduction to key considerations when developing a program or project. Ms. Wintering will provide an overview of strategic and tactical planning, stakeholder engagement and managing cross functional teams in program and project management. Mr. Redline will present on planning tools and methods including project constraints and project management processes to measure progress and evaluate project performance. The speakers will review processes and procedures from both a sponsor and site perspective.

3:15 - 3:30    Q&A / Break    

3:30 - 5:00     Project Management in Clinical Trials and Virtual Project Management: Introduction to PMI Principles
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Consultant 

It has become increasingly more important to use solid project management principles when managing clinical trials. Dr. Sivaramakrishna will introduce participants to project management  principles following Project Management Institute (PMI). A brief history of PMI, key terms, the project life cycle, and knowledge areas will be discussed. Additionally, clinical project management is done globally across multiple time zones and cultures. In order to be successful, certain adaptations have to be made to routine practices. Dr. Sivaramakrishna will discuss some of the challenges related to virtual project management and solutions for the same. Situational examples will be provided where applicable.


Day 2 - Wednesday


1:00-3:00 Creating a Study Budget and Managing Finances From Start Up to Close Out
Jennifer Goldfarb, MSN, RN, CCRP, Director, Pediatric Research, University of Minnesota

Ms. Goldfarb will discuss budget development and financial management topics including: general start up issues, study feasibility, potential pitfalls in budgeting, and strategies to manage impasses and identify hidden costs. The session will address study tracking and site management throughout the course of the study. This will include illustrating the use of tracking tools for financial management throughout the study conduct, including patient status and payment tracking. Ms. Goldfarb will also discuss approaches to program management, including staffing and effort tracking and management.

3:00 - 3:15    Q&A / Break   

3:15-4:45  Contract Development for Good Outcomes for Site and Sponsor
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC

Ms. Benson will discuss the contract review process and the importance of successful interactions between Sponsors, CROs and Sites when negotiating Clinical Trial Agreements. Ms. Benson will review key elements of a Clinical Trial Agreement and particularly focus on two key areas, Study Budgets and Payment Terms. Sponsors and Sites will have the opportunity to have open discussions with one another on the challenges that they face in regards to Study Budgets and Payment Terms to better understand one another’s perspective. Other terms to be reviewed are Intellectual Property, Monitoring Visits, Audits and Subject Injury. Ms. Benson will provided examples of tracking tools and how they relate to effective contract management.

 4:45 - 5:00    Q&A   


Day 3 - Thursday


1:00–3:00    Project Management Organization: Charts, Planning & Tracking, Tools & Techniques
Daniel Redline, BA, CCRP, Senior Director, Global Clinical Affairs, Align Technology, Inc.
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
Staying on track is a key to success in project management. This session will focus on developing and maintaining project management tools and techniques for project planning and assessment of progress. Gantt Charts, Standard Operating Procedures, file naming conventions, flowcharts, shared calendars to organize and manage the workplace will be discussed.

3:00 - 3:15    Q&A / Break  

3:15–4:45       Project Management in Clinical Trials: Project Management Knowledge Areas and Process Group Mapping
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Consultant

Dr. Sivaramakrishna will introduce participants to project management principles following PMI (Project Management Institute) guidelines as well as project management knowledge areas and process group mapping. Project management tools will be provided and discussed. Situational examples will be provided in order to maximize interaction and discussion.

4:45 - 5:00    Q&A  


Day 4 - Friday


1:00–2:30     Project Management in Clinical Trials: Risk Management and Risk Mitigation
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Consultant 

Dr. Sivaramakrishna will introduce basic principles of risk management, risk avoidance and risk mitigation. Project management tools will be provided and discussed. Situational examples will be provided in order to maximize interaction and discussion. Project management knowledge areas will be summarized.

2:30 - 2:45    Q&A / Break 

2:45 - 4:30    Organizational Dynamics in Project Management: Different Styles, Different Expectations
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University

Psychological issues may arise unexpectedly that have an impact on the activities and relationships in clinical trial management. This session is designed to build competencies to manage more effectively while working with different leadership and personality and organizational styles. Ms. Wintering will present strategies to recognize and resolve conflict proactively and to promote effective team building.

4:30 - 5:00   Q&A