Higher Education CoP - Management of Complex Projects Across Sites with Varying Skill Levels: Sponsor Perspective

Abstract

There is no one-size-fits all approach when managing a clinical trial across multiple sites. Several factors must be considered when ensuring that all sites will be successful on a single project. These factors include but are not limited to : site research experience, standard operating procedures, patient population, staff turnover, available technology and site workload. Without effective sites, the study can experience delays and even fail as a whole.

Each site may have its own barriers and it is crucial to have a carefully planned approach to project management while taking into account all stakeholders in the trial. The Janssen approach to site management is a carefully executed two-fold strategy by both the operational team and the clinical team. Since both facets have different perspectives and requirements within the trial, this creates a shared responsibility approach that has been very successful with our sites.

Inspection readiness is the backbone of our site management plan and shapes how we train and support our sites. We use numerous tools and innovative processes to aid in this practice. Our hope is that by sharing these concepts, the audience will gain a better understanding of how certain companies are evolving within the research industry in order to assess what is needed to better support our sites. In an industry that is so fast-paced, having an adaptable style of project management that prevents any delays at the site or sponsor level is crucial to the success of any trial. 

Learning Objectives

We will explore using an adaptable style of project management in a fast-paced environment and you will learn:

• Factors needed for successful clinical research sites
• A shared responsibility approach for clinical research site success
• Suggested tools and processes to ensure inspection readiness

Panelists

Jillian J. Saucier, MS, Sr. Local Trial Manager, Janssen Oncology

Jillian Saucier, MS is a Clinical Research professional with over 10 years of experience in the industry. In 2014 Jillian obtained a Masters of Clinical Research and Product Development from UNC Wilmington where she focused her Thesis on Treatment Disparities in Non-Small Cell Lung Cancer. Jillian began her research career as a study coordinator for South East Area Health Education Center where she worked for two years before joining PPD as a Research Coordination Specialist. In 2015, Jillian began working at Boston’s Dana Farber Cancer Institute in the Susan F. Smith Women’s Cancer Center where she monitored multi-center trials. After completing two years in an academic hospital setting, Jillian decided to join the Clinical Research Associate (CRA) team at PRA Health Sciences monitoring early phase oncology trials in a sponsor embedded program. After four years as a Sr. CRA, Jillian moved into to a Clinical Trial Manager (CTM) role in 2021 where she managed late phase oncology studies in an embedded program with Janssen Oncology- Solid tumor. After working for a year as a CTM with ICON, Jillian has since gone full -time with the sponsor and is now a Sr. Local Trial Manager for Janssen Pharmaceutical Companies of Johnson and Johnson in Oncology- Solid Tumor. Jillian thrives in the project management setting as she has a clear passion for leading others. With many years of experience as a CRA herself, Jillian immensely enjoys training newer CRAs. Through her 10+ years of experience in the industry, Jillian continues to obtain motivation from her most treasured career goal: to positively affect the lives of others through healthcare by helping to get more medicines to market.

Daneen Schaeffer, PhD, Director, Clinical Project Scientist, Janssen Oncology

In her current role, Daneen is a Clinical Project Scientist on the Phase 3 AMPLITUDE study, a trial designed to understand the safety and efficacy of a PARPi (niraparib) combined with an androgen biosynthesis inhibitor (abiraterone acetate) for the treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC). Daneen joined Janssen Oncology in 2015 as a Postdoctoral Fellow in the prostate Translational Research/biomarker group, followed by a role in U.S. Medical Affairs as a Solid Tumor Medical Science Liaison in the Southeastern U.S. Prior to joining Janssen, Daneen was a Postdoctoral Fellow at Duke University where her research focused on drivers of prostate cancer metastasis. Her findings shed light on the mechanistic differences between cancer cell migration and invasion. Daneen received her doctorate in Microbiology and Molecular Genetics from the University of Texas Health Science Center. Her doctoral research focused on mechanisms of RNA degradation and led to the identification of novel enzymatic activity involved in processing and degradation of normal and aberrant transcripts. She received her bachelor’s degree in Genetic Engineering from Cedar Crest College in Allentown, Pennsylvania.

This is a joint event between NCPMI Higher Education Community of Practice (HECoP) and the Duke Project Management CoP. The event is free and open to anyone interested in project management.

Notes:

1. This event is a Zoom-Only event
2. After registering and upon approval by the host, you will receive a confirmation email with instructions for joining the session. Please join the session shortly before 12:00 pm.