Agenda

Clinical Research Project/Program Management

For a printable PDF agenda, click here.

Day One 

8:00 - 8:30    Registration and Continental Breakfast

8:30 - 8:40    Introduction to SOCRA

8:40 - 10:15    Project Management - Developing an Infrastructure

Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
Daniel Redline, BA, CCRP, CIP, Director, Clinical Affairs, NeuroVision

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 Director Clinical Finance and Operational Excellence, Dynavax

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.

12:00 - 12:45     Lunch (Provided)

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

Daniel Redline, BA, CCRP, CIP, Director, Clinical Affairs, NeuroVision
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.

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 Director Clinical Finance and Operational Excellence, Dynavax

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.

4:30–5:00    Virtual Project Management

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP, Senior Director Clinical Finance and Operational Excellence, Dynavax

More and more, 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 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 Director Clinical Finance and Operational Excellence, Dynavax

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.

10:00–10:15    Break

10:15–11:45     Creating a Study Budget and Managing Finances From Start Up to Close Out

Jennifer Goldfarb, MSN, RN, CCRP, Senior Director, Clinical Research Support Office, Children’s Hospital of Philadelphia

Ms. Goldfarb will discuss budget development and fi nancial 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 tools such as budget benchmarking and cost funds fl ow in budgetary planning and study execution. Ms. Goldfarb will also highlight the importance of accurate research billing including billing to CMS (Centers for Medicare & Medicaid Services) and financial management throughout the study conduct, including patient status and payment tracking.

11:45–12:30   Lunch (Provided)

12:30–2:15     Contract Development for Good Outcomes for Site and Sponsor

Lisa Benson, BS, CCRP, VP Clinical Research Operations, Quality & Education, Institute of Advanced Clinical Trials for Children

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.

2:15–2:45     Planning for the Unexpected

Erich Lukas, MBA, Executive Director, Society of Clinical Research Associates

This session will consider various aspects of recovery planning. The environment, including natural and man-made disruptions and disasters, is full of scenarios to be considered by the project manager/planner. The discussion will include a view of current regulations and guidance regarding data management in view of the potential need for data, forms, and information recovery.

2:45–3:00     Break

3:00–4:15    Organizational Dynamics in Project Management: Different Styles, Diff erent 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 eff ectively while working with diff erent leadership and personality and organizational styles. Ms. Wintering will present strategies to recognize and resolve conflict proactively and to promote effective team building.

4:15–5:00      Managing Moves of Multiple Clinical and Research Programs

Lisa Benson, BS, CCRP, VP Clinical Research Operations, Quality & Education, Institute of Advanced Clinical Trials for Children

The speaker will provide a project management overview of the challenges and successes of moving multiple research programs to her institution, all at the same time. Topics will include project planning and management of both clinical/research staff,  laboratory moves, the regulatory documents needed, involvement and roles of multiple departments and knowing when to leverage key personnel to assist in program management to ensure successful outcomes.