Agenda

Clinical Research Project/Program Management Conference

Day One

8:00 - 8:30 Registration and Continental Breakfast

8:30 - 10:15 Project Management - Developing an Infrastructure

Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
Daniel Redline, BA, CCRP, CIP, Senior Director, Global Clinical Affairs, Align Technology, Inc.This session will provide an overview of the project management processes: (Initiation, Planning, Execution, Monitoring, Controlling, and Closing) as well as strategic and operational planning. The speakers will review processes and procedures from both sponsor and site perspectives that are necessary to develop an infrastructure and to manage the cross-functional research team that supports the various tasks and stakeholder relationships associated with project management.

10:15 - 10:30 Break

10:30 - 12:00 Project Management in Clinical Trials: Introduction to PMI Principles

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative

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.

12:00 - 12:45 Lunch (Provided)

12:45–2:45 Project Management Organization: Charts, Planning & Tracking, Tools & Techniques

Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
Daniel Redline, BA, CCRP, CIP, Senior Director, Global Clinical Affairs, Align Technology, Inc.
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.

2:45–3:00 Break

3:00–4:30 Project Management in Clinical Trials: Project Management Knowledge Areas and Process Group Mapping

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative

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.

4:30 to 5:00 Q+A and Day 1 Wrap-up

Day Two

8:00–8:30 Continental Breakfast

8:30–10:00 Project Management in Clinical Trials: Risk Management and Risk Mitigation

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative

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.

10:00 to 10:15 Break

10:15 -12:15 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.

12:15 to 1:00 Lunch (Provided)

1:00–2:45 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 regard 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 provide examples of tracking tools and how they relate to effective contract management.

2:45–3:00 Break

3:00–4:30 Organizational Dynamics in Project Management: Different Styles, Different Expectations
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University, Marcus Institute of Integrative Medicine
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.

4:30–4:45 Q+A and Conference Wrap-up